GCDClass I
Connector, Catheter
21 CFR 878.4200 / General, Plastic Surgery
GCD is the FDA product code for Connector, Catheter, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- GCD
- Device name
- Connector, Catheter
- Regulation
- 21 CFR 878.4200
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 7
Clearances, product code GCD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1985 | 2 |
| 1986 | 1 |
| 1994 | 1 |
| 1995 | 1 |
Applicants with the most clearances
Product code GCD| Applicant | Clearances |
|---|---|
| Sil-Med Corp. | 2 |
| Angiomed U.S., Inc. | 1 |
| B. Braun Instruments | 1 |
| Ipco Corp. | 1 |
| Luther Medical Products, Inc. | 1 |
| R-Group Intl. | 1 |
| Sherwood Medical Industries | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3-D Matrix, Inc.
- AD Supply Group Limited
- Aesthetic experts labs Ltd
- Amsino Medical (Kunshan) Co., Ltd.
- Asomedica Co. Ltd
- Baby Health Care, Inc.
- Boen Healthcare Co., Ltd.
- C.R. Bard Inc
- Cardinal Health (Kenmex Medical Specialties)
- Cardinal Health P.R. 218, Inc.
- CBR Enterprise Limited
- Changshu Rozer Sterilization Technology Co., Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
