HFI
8 FDA 510(k) clearances · Product code
507 daysmedian time to decision
560 days90th percentile
8clearances measured
FDA profile
- Official device name
- Coagulator, Culdoscopic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ENDOPLUS hand-held laparoscopic instruments (K151567) | Endoplus | 2015-12-23 |
| FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (K925960) | Zinnanti Surgical Instruments, Inc. | 1994-06-07 |
| SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (K925957) | Zinnanti Surgical Instruments, Inc. | 1994-06-07 |
| COOK LAPAROSCOPIC MINI RETRACTOR SET (K936026) | Cook Urological, Inc. | 1994-03-11 |
| LAPAROSCOPIC INSTRUMENTS (K925114) | Endo Technic Corp. | 1994-02-28 |
| DIAMOND-SHARP(R) TROCARS (K924148) | Snowden-Pencer | 1994-02-28 |
| REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING (K930571) | Numed Technologies, Inc. | 1994-02-01 |
| CANON 60 DEGREE FUNDUS CAMERA CF-60S (K844053) | Canon USA, Inc. | 1984-12-19 |
Track HFI automatically
Every clearance here is in the API, with alerts when new ones post.