GCM · Class II · 21 CFR 876.1500

FDA Product Code GCM: Endoscope, Rigid

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Smith & Nephew Richards, Inc. and Laser Optik Systeme GmbH & Co. KG.

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 Sep 28, 2009
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
K083840
Msi Medserv International Deutschland GmbH
Gastroenterology & Urology · 278d
Cleared Jul 11, 2000
INSIDE VIEW
K001217
Monadnock Optics, Inc.
Gastroenterology & Urology · 85d
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 Aug 17, 1993
FIBER OPTIC ENDOSCOPE
K921918
Electro Fiberoptics Corp.
Gastroenterology & Urology · 481d
Cleared Feb 12, 1993
PRESSURE TURING AND ACCESSORIES
K925918
Applied Medical Resources
Gastroenterology & Urology · 81d
Cleared Nov 23, 1992
ENDOSCOPE
K921883
Optimed Technologies, Inc.
Gastroenterology & Urology · 216d
Cleared Aug 07, 1990
MEDILASE SERIES 2200 ENDOSCOPE
K901464
Medical Laser, Inc.
Gastroenterology & Urology · 132d
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