GCB
8 FDA 510(k) clearances · Product code
85 daysmedian time to decision
231 days90th percentile
8clearances measured
FDA profile
- Official device name
- Needle, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2017: 19 · 2018: 25 · 2019: 46 · 2020: 72 · 2021: 19 · 2022: 23
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 |
|---|---|---|
| Valved Safety Centesis Catheter (K150800) | B.Braun Medical, Inc. | 2015-11-12 |
| PARACENTESIS CATHETER DEVICE (K974146) | Allegiance Healthcare Corp. | 1998-01-28 |
| ADAIR/VERESS NEEDLE INTRODUCER SET (K930568) | Medical Dynamics, Inc. | 1993-07-22 |
| TURKEL PNEUMOTHORAX KIT (K923028) | Symbiosis Corp. | 1992-08-04 |
| ADAIR/VERESS NEEDLE INTRODUCER SET (K900374) | Medical Dynamics, Inc. | 1990-04-20 |
| SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (K854327) | Concord Laboratories, Inc. | 1985-11-13 |
| MANAN EPIDURAL NEEDLE (K852428) | Manan Manufacturing Co., Inc. | 1985-06-27 |
| NEEDLES, DESIGN CHANGE, IV CATHETERS (K780896) | Jelco Laboratories | 1978-08-23 |
Track GCB automatically
Every clearance here is in the API, with alerts when new ones post.