FDC · Class II · 21 CFR 876.1500

FDA Product Code FDC: Resectoscope, Working Element

Leading manufacturers include V. Mueller O.V. Baxter Healthcare Corp., Orthoconcept, Inc. and Gm Engineering, Inc..

11
Total
11
Cleared
113d
Avg days
1976
Since

FDA 510(k) Cleared Resectoscope, Working Element Devices (Product Code FDC)

11 devices
1–11 of 11
Cleared May 09, 2002
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
K021166
Acmi-Circon Corporation
Gastroenterology & Urology · 28d
Cleared Sep 29, 1999
OLYMPUS WORKING ELEMENT FOR PROBES
K992141
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 97d
Cleared Aug 05, 1999
MAHE INSTRUMENTS
K991426
Mahe Intl., Inc.
Gastroenterology & Urology · 104d
Cleared May 30, 1995
CONTINUOUS FLOW BIOPSY PROBE
K942626
Gm Engineering, Inc.
Gastroenterology & Urology · 362d
Cleared Feb 25, 1994
GM CONTINUOUS FLOW BIOPSY PROBE
K933962
Gm Engineering, Inc.
Gastroenterology & Urology · 196d
Cleared Oct 17, 1989
MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
K895643
Orthoconcept, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 11, 1989
UROPUMP* FLUID MANAGEMENT SYSTEM
K894363
Orthoconcept, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 27, 1984
LASER RECTOSCOPE SET 784
K842997
Laser Industries , Ltd.
Gastroenterology & Urology · 28d
Cleared Dec 02, 1976
SHEATH, RESECTOSCOPE
K760182
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 149d
Cleared Dec 02, 1976
ELEMENT, WORKING
K760184
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 149d
Cleared Aug 30, 1976
ADAPTER, RESECTOSCOPE
K760174
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 55d

About Product Code FDC - Regulatory Context