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FDA PRODUCT CODE · CLASS II

FAJ — Cystoscope And Accessories, Flexible/Rigid

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
17
510(K)/PMA CLEARANCES
510k: 17
0
RECALL ENTRIES

Recent clearances

K260649Olympus Winter & Ibe GmbH · 510k2026-05-21
K253696Verathon Medical (Canada) Ulc · 510k2026-05-11
K253892Strauss Surgical USA · 510k2026-04-16
K253905Cogentix Medical, Inc. · 510k2026-04-07
K260271American Medical Endoscopy, Inc. · 510k2026-03-27
K253226Uroviu Corporation · 510k2025-10-23
K251140Zenflow, Inc. · 510k2025-09-23
K252598Shanghai AnQing Medical Instrument Co., Ltd. · 510k2025-09-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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