GCM — Endoscope, Rigid Class II
FDA product code GCM covers "Endoscope, Rigid", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCM
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203226 | richard wolf medical instruments corporation | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM | May 14, 2021 |
| K083840 | msi medserv international deutschland | MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE | September 28, 2009 |
| K001217 | monadnock optics | INSIDE VIEW | July 11, 2000 |
| K993103 | richard wolf medical instruments | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOS | December 10, 1999 |
| K993445 | omnisonics medical technologies | OMNISONIC ENDOSCOPIC DEFLECTOR | December 6, 1999 |
| K962393 | karl storz endoscopy-america | KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION | September 17, 1996 |
| K950712 | laser-optik-systeme gmbh and co. kg | PORTABLE ENDOSCOPY SYSTEM | May 14, 1996 |
| K955120 | ethicon endo-surgery | HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR | January 26, 1996 |
| K935235 | smith and nephew richards | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY | March 23, 1995 |
| K945889 | karl storz endoscopy-america | KARL STORZ PLASTIC SURGERY ACCESSORIES | March 22, 1995 |
| K931954 | surgical technologies | THORACOSCOPE/LAPAROSCOPE | November 2, 1993 |
| K921918 | electro fiberoptics | FIBER OPTIC ENDOSCOPE | August 17, 1993 |
| K925918 | applied medical resources | PRESSURE TURING AND ACCESSORIES | February 12, 1993 |
| K921883 | optimed technologies | ENDOSCOPE | November 23, 1992 |
| K901464 | medical laser | MEDILASE SERIES 2200 ENDOSCOPE | August 7, 1990 |
| K894592 | marlo surgical technology | LAMANO DIRECTORS | September 8, 1989 |
| K853514 | american edwards laboratories | RIGID ENDOSCOPE | October 4, 1985 |
| K844769 | microvasive | RIGID FIBEROPITC ENDOSCOPE | January 15, 1985 |