Product code GCM— Gastroenterology, Urology
ENDOSCOPE
- Classification name
- Endoscope, Rigid
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code GCM
FDA has cleared devices under product code GCM between 1985 and 2021, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2009
- 2000
- 1999
- 1996
- 1995
- 1993
- 1992
- 1990
- 1989
- 1985
Top applicants under product code GCM
- KARL STORZ Endoscopy-America, Inc.
- Surgical Technologies, Inc.
- Smith & Nephew Richards, Inc.
- Richard Wolf Medical Instruments Corporation
- Richard Wolf Medical Instruments Corp.
- Optimed Technologies, Inc.
- Omnisonics Medical Technologies
- Msi Medserv International Deutschland GmbH
- Monadnock Optics, Inc.
- Microvasive
Adverse events under product code GCM
product code GCM- Malfunction
- 1,233
- Total
- 1,233
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GCM
- K203226 — 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
- K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
- K001217 — INSIDE VIEW
- K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
- K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR
- K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
- K950712 — PORTABLE ENDOSCOPY SYSTEM
- K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
- K935235 — ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
- K945889 — KARL STORZ PLASTIC SURGERY ACCESSORIES
- K931954 — THORACOSCOPE/LAPAROSCOPE
- K921918 — FIBER OPTIC ENDOSCOPE
- K925918 — PRESSURE TURING AND ACCESSORIES
- K921883 — ENDOSCOPE
- K901464 — MEDILASE SERIES 2200 ENDOSCOPE
- K894592 — LAMANO DIRECTORS
- K853514 — RIGID ENDOSCOPE
- K844769 — RIGID FIBEROPITC ENDOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.