GCP — Endoscope, Ac-Powered And Accessories Class II
FDA product code GCP covers "Endoscope, Ac-Powered And Accessories", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCP
- 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 |
|---|---|---|---|
| K954614 | north eos industries | EOS BRAND DISPOSABLE PROCTOSCOPE | April 10, 1996 |
| K896505 | porges | PORGES UNIVERSAL HANDLES | January 30, 1990 |
| K896008 | medical dynamics | MODEL 6500 MERCURY ARC LIGHT SOURCE | December 27, 1989 |
| K862424 | endovations | STEERABLE CATHETER SYSTEM | September 22, 1986 |
| K860103 | endotherapeutics | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | February 12, 1986 |
| K843683 | reichert scientific instruments | MODULAR FIBERSCOPE SYSTEM | January 18, 1985 |
| K833859 | american endoscopy | TAMPONADE BALLOON CUFF | January 3, 1984 |
| K821999 | retech | ENDOSCOPIC SCLEROTHERAPY BALLOON | August 27, 1982 |
| K801247 | welch allyn | CCD ENDOSCOPE AND ATTACHMENTS | July 28, 1980 |
| K790071 | olympus | ENDOSCOPE AND ACCESSORIES | April 2, 1979 |
| K771920 | propper mfg. co | FIBER OPTICS PROCTOSCOPE | October 20, 1977 |
| K771919 | propper mfg. co | FIBER OPTICS SIGMOIDOSCOPE | October 20, 1977 |
| K771918 | propper mfg. co | FIBEO OPTICS ILLUM. SYSTEM | October 20, 1977 |