GCC — Dilator, Catheter Class I
FDA product code GCC covers "Dilator, Catheter", a Class I medical device regulated under 21 CFR 878.4200. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCC
- Device Class
- Class I
- Regulation Number
- 878.4200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981061 | med institute | INTRAVASCULAR RETRIEVAL DEVICE | May 26, 1998 |
| K922354 | med institute | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | July 30, 1992 |
| K902502 | medical engineering and development institute | BYRD STAINLESS STEEL DILATOR | August 7, 1990 |
| K893480 | medical engineering and development institute | BYRD EXTRACTOR SET | June 23, 1989 |
| K820865 | van-tec | VAN-TEC FASCIAL DILATOR | May 5, 1982 |