GBB
8 FDA 510(k) clearances · Product code
38 daysmedian time to decision
154 days90th percentile
8clearances measured
FDA profile
- Official device name
- Chair, Surgical, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2007: 3 · 2010: 5 · 2011: 18 · 2012: 14 · 2013: 10 · 2021: 13
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 |
|---|---|---|
| TENET TIBIAL FRACTURE SUPPORT (K964102) | Tenet Medical Engineering | 1996-12-05 |
| HYDRAULIC FOOT OPERATED STOOL (K893598) | Arthro-Medic, Inc. | 1989-10-10 |
| LITHOTOMY CHAIR #415 (K831385) | Midmark Corp. | 1983-06-02 |
| NUTROMAT (K831325) | Medlog GmbH Marketing Services | 1983-06-02 |
| NAGASHIMA SN OPERATOR'S CHAIR (K822264) | Kelleher Corp. | 1982-10-13 |
| EXAMINATION & TREATMENT CHAIRS (K822251) | Kelleher Corp. | 1982-08-27 |
| NAGASHIMA SN AUTOMATIC TREATMENT CHAIR (K822013) | Kelleher Corp. | 1982-07-28 |
| STORZ #6500 POWER EXAMINATION CHAIR (K820636) | Storz Instrument Co. | 1982-03-26 |
Track GBB automatically
Every clearance here is in the API, with alerts when new ones post.