FDCClass II

Resectoscope, Working Element

21 CFR 876.1500 / Gastroenterology, Urology

FDC is the FDA product code for Resectoscope, Working Element, a class II device type, regulated under 21 CFR 876.1500. As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 2002-05-09, and no recalls.

Classification record

Product code: FDC
Device name: Resectoscope, Working Element
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: 11
Ingested recalls: 0

Clearances, product code FDC

By decision year

11 clearances under product code FDC with a decision year between 1976 and 2002, 1976 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code FDC by decision year
Year	Clearances
1976	3
1984	1
1989	2
1994	1
1995	1
1999	2
2002	1

Applicants with the most clearances

Product code FDC

Applicants holding the most 510(k) clearances under product code FDC
Applicant	Clearances
V. Mueller O.V. Baxter Healthcare Corp.	3
Gm Engineering, Inc.	2
Orthoconcept, Inc.	2
Acmi-Circon Corporation	1
Laser Industries, Ltd.	1
Mahe Intl., Inc.	1
Olympus Winter & Ibe GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order