FASClass II

Electrode, Electrosurgical, Active, Urological

21 CFR 876.4300 / Gastroenterology, Urology

FAS is the FDA product code for Electrode, Electrosurgical, Active, Urological, a class II device type, regulated under 21 CFR 876.4300. As of 2026-09-10, FDA records hold 58 510(k) clearances under this code, the most recent dated 2025-12-05, and 9 recalls.

Classification record

Product code: FAS
Device name: Electrode, Electrosurgical, Active, Urological
Regulation: 21 CFR 876.4300
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: Yes
Ingested clearances: 58
Ingested recalls: 9

Clearances, product code FAS

By decision year

58 clearances under product code FAS with a decision year between 1990 and 2025, 1997 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code FAS by decision year
Year	Clearances
1990	2
1991	1
1992	1
1994	5
1995	4
1996	8
1997	9
1998	3
1999	1
2002	1
2003	2
2005	3
2006	2
2010	3
2011	1
2012	2
2015	1
2016	1
2017	2
2021	2
2022	1
2024	1
2025	2

Applicants with the most clearances

Product code FAS

Applicants holding the most 510(k) clearances under product code FAS
Applicant	Clearances
Olympus Winter & Ibe GmbH	6
ArthroCare Corporation	5
Omnitech Systems, Inc.	4
Greenwald Surgical Co., Inc.	3
American Medical Systems, Inc.	2
Applied Urology, Inc.	2
C.R. Bard Inc	2
Chirurgie Innovation	2
Endolap, Inc.	2
Gyrus ACMI, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order