FAJClass II

Cystoscope And Accessories, Flexible/Rigid

21 CFR 876.1500 / Gastroenterology, Urology

FAJ is the FDA product code for Cystoscope And Accessories, Flexible/Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 92 510(k) clearances under this code, the most recent dated 2026-05-21, and 22 recalls.

Classification record

Product code: FAJ
Device name: Cystoscope And Accessories, Flexible/Rigid
FDA definition: 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).
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 92
Ingested recalls: 22

Clearances, product code FAJ

By decision year

92 clearances under product code FAJ with a decision year between 1976 and 2026, 2024 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code FAJ by decision year
Year	Clearances
1976	3
1982	1
1986	1
1989	1
1990	1
1992	1
1993	2
1994	4
1995	2
1996	1
1997	2
1998	3
1999	3
2000	2
2001	3
2002	1
2003	2
2004	3
2005	3
2006	1
2007	2
2009	2
2010	1
2012	1
2014	1
2016	1
2017	2
2018	2
2019	3
2020	2
2021	3
2022	5
2023	5
2024	9
2025	8
2026	5

Applicants with the most clearances

Product code FAJ

Applicants holding the most 510(k) clearances under product code FAJ
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	8
Uroviu Corporation	7
Ambu A/S	5
Cogentix Medical, Inc.	4
Guangzhou Red Pine Medical Instrument Co.,Ltd.	3
V. Mueller O.V. Baxter Healthcare Corp.	3
Acmi Corporation	2
American Medical Endoscopy	2
Hunan Vathin Medical Instrument Co., Ltd.	2
OTU Medical Inc	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 125 companies shown, in name order