HCF
5 FDA 510(k) clearances · Product code
75 daysmedian time to decision
130 days90th percentile
5clearances measured
FDA profile
- Official device name
- Instrument, Ligature Passing And Knot Tying
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 46 · 2022: 68 · 2023: 57 · 2024: 124 · 2025: 78 · 2026: 58
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 |
|---|---|---|
| Edwards Suture Fastening System (K150882) | Edwards Lifesciences, LLC | 2015-06-16 |
| MICROVASIVE INSURG LAPTIE SUTURE LIGATOR (K931379) | Boston Scientific Corp | 1993-07-13 |
| VALTRAC PURSESTING DEVICE (K851452) | Davis & Geck, Inc. | 1985-06-12 |
| STROVER HOOK (K841617) | Plastafil, Inc. | 1984-08-27 |
| HEMORRHOIDAL LIGATOR (K790577) | J. Sklar Mfg. Co., Inc. | 1979-04-23 |
Track HCF automatically
Every clearance here is in the API, with alerts when new ones post.