HBT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Applier, Hemostatic Clip
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2014: 153 · 2015: 17 · 2016: 11 · 2017: 20 · 2018: 25 · 2022: 15
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 |
|---|---|---|
| REFLEX(R) ECA (K924929) | Richard-Allan Medical | 1993-07-21 |
| TITANIUM LIGATING CLIPS (K896262) | Richard-Allan Medical Ind., Inc. | 1990-01-02 |
| TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP (K862696) | Downs Surgical , Ltd. | 1986-07-30 |
| DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI (K800318) | Edward Weck, Inc. | 1980-03-10 |
Track HBT automatically
Every clearance here is in the API, with alerts when new ones post.