FEBClass II

Accessories, Cleaning, For Endoscope

21 CFR 876.1500 / Gastroenterology, Urology

FEB is the FDA product code for Accessories, Cleaning, For Endoscope, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 57 510(k) clearances under this code, the most recent dated 2024-12-19, and 40 recalls.

Classification record

Product code: FEB
Device name: Accessories, Cleaning, For Endoscope
FDA definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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: 57
Ingested recalls: 40

Clearances, product code FEB

By decision year

57 clearances under product code FEB with a decision year between 1981 and 2024, 1994 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code FEB by decision year
Year	Clearances
1981	1
1982	1
1983	1
1984	1
1985	1
1990	1
1991	1
1992	4
1993	5
1994	6
1995	2
1996	1
1997	2
2000	1
2001	1
2005	1
2006	2
2007	2
2008	1
2009	1
2010	2
2011	3
2012	1
2013	1
2014	1
2016	2
2017	2
2018	1
2019	2
2020	2
2022	1
2023	1
2024	2

Applicants with the most clearances

Product code FEB

Applicants holding the most 510(k) clearances under product code FEB
Applicant	Clearances
Wassenburg Medical B.V.	5
Medivators Inc	5
Olympus Medical Systems Corp.	5
Advanced Sterilization Products	4
Keymed, Inc.	4
Cox Medical Ent., Inc.	3
Medivators Reprocessing Systems	3
STERIS Corporation	3
Advanced Sterilization Products (Asp)	2
Blue Planet Industries, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order