GCM · Class II · 21 CFR 876.1500

FDA Product Code GCM: Endoscope, Rigid

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Richard Wolf Medical Instruments Corp. and Omnisonics Medical Technologies.

18
Total
18
Cleared
176d
Avg days
1985
Since

FDA 510(k) Cleared Endoscope, Rigid Devices (Product Code GCM)

18 devices
1–18 of 18
Cleared May 14, 2021
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
K203226
Richard Wolf Medical Instruments Corporation
General & Plastic Surgery · 193d
Cleared Dec 10, 1999
ENDOSCOPES,10MM DIAMETER 0 DEGREES
K993103
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 85d
Cleared Dec 06, 1999
OMNISONIC ENDOSCOPIC DEFLECTOR
K993445
Omnisonics Medical Technologies
Gastroenterology & Urology · 55d
Cleared Sep 17, 1996
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
K962393
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 89d
Cleared May 14, 1996
PORTABLE ENDOSCOPY SYSTEM
K950712
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 455d
Cleared Jan 26, 1996
HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
K955120
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 78d
Cleared Mar 23, 1995
ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
K935235
Smith & Nephew Richards, Inc.
Gastroenterology & Urology · 507d
Cleared Mar 22, 1995
KARL STORZ PLASTIC SURGERY ACCESSORIES
K945889
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 111d
Cleared Nov 02, 1993
THORACOSCOPE/LAPAROSCOPE
K931954
Surgical Technologies, Inc.
Gastroenterology & Urology · 196d
Cleared Feb 12, 1993
PRESSURE TURING AND ACCESSORIES
K925918
Applied Medical Resources
Gastroenterology & Urology · 81d
Cleared Sep 08, 1989
LAMANO DIRECTORS
K894592
Marlo Surgical Technology
Gastroenterology & Urology · 46d
Cleared Oct 04, 1985
RIGID ENDOSCOPE
K853514
American Edwards Laboratories
Gastroenterology & Urology · 43d
Cleared Jan 15, 1985
RIGID FIBEROPITC ENDOSCOPE
K844769
Microvasive
Gastroenterology & Urology · 39d

About Product Code GCM - Regulatory Context