Atlas FDA

ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM

FDA 510(k) clearance K012883 · decided 2001-10-12

Clearance details

K-number
K012883
Device name
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
Applicant
Boston Scientific Corp
Decision
Unknown
Date received
2001-08-28
Decision date
2001-10-12
Days to decision
45 days
Clearance type
Special
Product code
ESW
Device class
2
Regulation number
878.3610
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Natick,, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978)Boston Scientific Corporation2026-07-10
Niti-S Esophageal Stent; Esophageal TTS Stent (K243619)Taewoong Medical Co., Ltd.2025-10-30
HANAROSTENT Esophagus Upper (CCC) (K253327)M.I.Tech Co., Ltd.2025-10-30
Resilience Fully Covered Esophageal Stent System (K251265)Merit Medical Systems, Inc.2025-07-23
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939)Boston Scientific2024-04-29
Agile Esophageal Stent System (K233837)Boston Scientific Corporation2024-04-04
Esophageal TTS Stent (K240522)Taewoong Medical2024-03-22
Hilzo Esophageal Stents (K223266)Thoracent, Inc.2024-01-16
Esophageal TTS Stent (K221482)Taewoong Medical Co., Ltd.2022-06-22
Agile Esophageal OTW Stent System (K211960)Boston Scientific Corporation2021-11-22
HANAROSTENT Esophagus Asymmetric (CCC) (K213251)M.I.Tech Co., Ltd.2021-11-18
Esophageal TTS Stent (K211706)Taewoong Medical Co., Ltd.2021-10-08

Recalls involving this device

RecordFirmDate
Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release (10 recall (Z-2325-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/ recall (Z-2326-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (14/4/2 recall (Z-2327-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4 recall (Z-2328-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (18/4/2 recall (Z-2329-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (20/6/4 recall (Z-2330-2010)Boston Scientific Corporation2010-08-31
Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. Singl recall (Z-1817-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 8/40 Catalog Number: M00568930. Singl recall (Z-1818-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog Number: M00568940. Sing recall (Z-1819-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950. Sing recall (Z-1820-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog Number: M00568960. Sing recall (Z-1821-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970. Sing recall (Z-1822-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Sing recall (Z-1823-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/80 Catalog Number: M00569000. Sing recall (Z-1824-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040. Sin recall (Z-1825-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050. Sin recall (Z-1826-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060. Sin recall (Z-1827-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070. Sing recall (Z-1828-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080. Sing recall (Z-1829-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090. Sing recall (Z-1830-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230. Sing recall (Z-1831-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog Number: M00569240. Sing recall (Z-1832-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250. Sing recall (Z-1833-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. Sing recall (Z-1834-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. Sing recall (Z-1835-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280. Sing recall (Z-1836-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290. Sing recall (Z-1837-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. Sing recall (Z-1838-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Sing recall (Z-1839-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog Number: M00569410. Sing recall (Z-1840-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430. Sin recall (Z-1841-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450. Sin recall (Z-1842-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480. Sin recall (Z-1843-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog Number: M00569490. Sin recall (Z-1844-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 18/40/65 Catalog Number: M00569500. Sin recall (Z-1845-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510. Sin recall (Z-1846-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520. Sin recall (Z-1847-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530. Sin recall (Z-1848-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. Sin recall (Z-1849-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog Number: M00569550. Sin recall (Z-1850-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560. Sin recall (Z-1851-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog Number: M00569570. Sin recall (Z-1852-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. Sin recall (Z-1853-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590. Sin recall (Z-1854-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920. Sing recall (Z-1855-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 14/60 Catalog Number: M00569930. Single recall (Z-1856-2010)Boston Scientific Corporation2010-06-25

PMA approvals by this applicant

RecordFirmDate
Epic™ Vascular Self-Expanding Stent System (P110035/S078)Boston Scientific Corp2026-08-06
Eluvia™ Drug-Eluting Vascular Stent System (P180011/S069)Boston Scientific Corp2026-08-06
MOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138 (P010012/S613)Boston Scientific Corp2026-07-23
ESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201) (N970003/S309)Boston Scientific Corp2026-07-23
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage Closure (P130013/S086)Boston Scientific Corp2026-07-21
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S096)Boston Scientific Corp2026-07-16
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S397)Boston Scientific Corp2026-07-10
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S095)Boston Scientific Corp2026-07-10