Atlas FDA

BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

FDA 510(k) clearance K965147 · decided 1997-06-30

Clearance details

K-number
K965147
Device name
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
1996-12-23
Decision date
1997-06-30
Days to decision
189 days
Clearance type
Traditional
Product code
FGE
Device class
2
Regulation number
876.5010
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Natick,, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
ARCHIMEDES Biodegradable Stent (Medium) (K260835)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2026-07-27
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 (K253393)Hangzhou AGS MedTech Co., Ltd.2026-06-24
Dilation Balloon Catheter (K253832)Mirco-Tech (Nanjing) Co., Ltd.2026-04-24
Endoflux™ Biliary & Pancreatic Stent Sets (K251658)Medi-Globe GmbH2026-04-16
BARE Wireguided Balloon Dilation Catheter (1235) (K253987)GIE Medical2026-03-13
Single use stone retrieval balloons (K253132)Zhejiang Chuangxiang Medical Technology Co., Ltd.2026-03-06
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (K251123)Taewoong Medical Co., Ltd.2025-12-29
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (K251019)Bioteque Corporation2025-12-22
Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (K250409)Olympus Medical Systems Corporation2025-10-21
EndoFix™Tissue Fixation System (K251229)Softac Medical Technologies2025-08-20
ARCHIMEDES Biodegradable Pancreatic Stent (K243412)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2025-07-16
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K251291)Boston Scientific2025-07-03

Recalls involving this device

RecordFirmDate
FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, recall (Z-197-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, recall (Z-1975-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, recall (Z-1976-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, recall (Z-1977-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, recall (Z-1979-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer recall (Z-1980-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific, Spencer recall (Z-1981-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific, Spence recall (Z-1982-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO, Boston Scientific, Spence recall (Z-1983-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific, Spence recall (Z-1984-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific, Spencer, recall (Z-1985-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific, Spencer, recall (Z-1986-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO, Boston Scientific, Spencer recall (Z-1987-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer recall (Z-1988-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO, Boston Scientific, Spencer recall (Z-1989-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific, Spence recall (Z-1990-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO, Boston Scientific, Spence recall (Z-1991-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific, Spenc recall (Z-1992-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific, Spenc recall (Z-1993-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spenc recall (Z-1994-2010)Boston Scientific Corporation2010-08-25
Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Bos recall (Z-2105-2008)Boston Scientific Corp2008-09-11

PMA approvals by this applicant

RecordFirmDate
ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15