GCD
8 FDA 510(k) clearances · Product code
70 daysmedian time to decision
336 days90th percentile
8clearances measured
FDA profile
- Official device name
- Connector, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1995: 1 · 2005: 3 · 2015: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (K952470) | R-Group Intl. | 1995-11-28 |
| L-CATH CONNECTOR ASSEMBLY (K940198) | Luther Medical Products, Inc. | 1994-12-15 |
| ANGIOMED HIGH PRESSURE CONNECTORS (K863446) | Angiomed U.S., Inc. | 1986-09-23 |
| INCISION DRAIN (K851196) | Sil-Med Corp. | 1985-06-04 |
| Y CONNECTOR (K851921) | Sil-Med Corp. | 1985-05-17 |
| CONNECTORS (K760382) | B. Braun Instruments | 1976-11-02 |
| CATHETER CONNECTOR, ARGYLE TUBING (K760524) | Sherwood Medical Industries | 1976-11-02 |
| TUBE, STERILE NON-CONDUCTIVE CONNECTING (K760203) | Ipco Corp. | 1976-07-19 |
Track GCD automatically
Every clearance here is in the API, with alerts when new ones post.