Atlas FDA

CUSTOMED CYSTO PACK I

FDA 510(k) clearance K902274 · decided 1990-09-20

Clearance details

K-number
K902274
Device name
CUSTOMED CYSTO PACK I
Applicant
Customed, Inc.
Decision
Unknown
Date received
1990-05-21
Decision date
1990-09-20
Days to decision
122 days
Clearance type
Traditional
Product code
FAJ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Puerto Rico, 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
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, (K260649)Olympus Winter & Ibe GmbH2026-05-21
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) (K253696)Verathon Medical (Canada) Ulc2026-05-11
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, (K253892)Strauss Surgical USA2026-04-16
PrimeSight UltraView System (K253905)Cogentix Medical, Inc.2026-04-07
Strauss Surgical cystoscope, hysteroscope and accessories Instruments (K260271)American Medical Endoscopy, Inc.2026-03-27
UV5000W Handle (K253226)Uroviu Corporation2025-10-23
Zenflow Spring Scope (K251140)Zenflow, Inc.2025-09-23
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K252598)Shanghai AnQing Medical Instrument Co., Ltd.2025-09-15
UV5000 Handle (K250797)Uroviu Corporation2025-09-11
KARL STORZ HOPKINS Telescopes for Urology (K243653)Karl Storz SE & CO. KG2025-08-13
Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K252176)Guangzhou Red Pine Medical Instrument Co., Ltd.2025-08-08
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo (K251652)American Medical Endoscopy, Inc.2025-08-01

Recalls involving this device

RecordFirmDate
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical recall (Z-1407-2016)Customed, Inc2016-04-14
Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical recall (Z-1463-2016)Customed, Inc2016-04-14
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform su recall (Z-2558-2015)Customed, Inc2015-09-03
CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and patient recall (Z-2660-2015)Customed, Inc2015-09-03
CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care recall (Z-2678-2015)Customed, Inc2015-09-03