FDA product code GCM: Endoscope, Rigid
GCM is the FDA product code for endoscope, rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under GCM, from 17 different applicants. The average 510(k) review took 176 days (median 100).
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Rigid |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for GCM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 193 |
Compare with all 510(k) review times · Search every GCM clearance
Top GCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 2 | 1996-09-17 |
| Richard Wolf Medical Instruments Corporation | 1 | 2021-05-14 |
| Msi Medserv International Deutschland GmbH | 1 | 2009-09-28 |
| Monadnock Optics, Inc. | 1 | 2000-07-11 |
| Richard Wolf Medical Instruments Corp. | 1 | 1999-12-10 |
12 more applicants have GCM clearances. See the full list in Caduvo.
Most recent GCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203226 | Richard Wolf Medical Instruments Corporation | 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 | 2021-05-14 | 193 |
| K083840 | Msi Medserv International Deutschland GmbH | MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE | 2009-09-28 | 278 |
| K001217 | Monadnock Optics, Inc. | INSIDE VIEW | 2000-07-11 | 85 |
| K993103 | Richard Wolf Medical Instruments Corp. | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES | 1999-12-10 | 85 |
| K993445 | Omnisonics Medical Technologies | OMNISONIC ENDOSCOPIC DEFLECTOR | 1999-12-06 | 55 |
Recalls for GCM devices
openFDA lists no recalls for product code GCM.
Frequently asked questions
What is FDA product code GCM?
GCM is the FDA product code for endoscope, rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCM?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCM?
Across 18 cleared submissions the average was 176 days from receipt to decision (median 100).
Which companies have the most GCM clearances?
KARL STORZ Endoscopy-America, Inc. (2); Richard Wolf Medical Instruments Corporation (1); Msi Medserv International Deutschland GmbH (1); Monadnock Optics, Inc. (1); Richard Wolf Medical Instruments Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GCM
- Run a recall and safety report across every GCM manufacturer
- Watch product code GCM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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