HGE
6 FDA 510(k) clearances · Product code
88 daysmedian time to decision
439 days90th percentile
6clearances measured
FDA profile
- Official device name
- Amniotome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1993: 3 · 1994: 1 · 2002: 1
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 |
|---|---|---|
| OBSTI-HOOK (K951148) | Onli | 1995-06-09 |
| AMNIPERF(TM) (K926425) | Raymart Development Co. | 1994-03-07 |
| GLOVE-N-GEL AMNIOTOMY KIT (K910518) | Epcom Medical Systems, Inc. | 1991-05-09 |
| S.C.M.T. PERFORATOR (K871087) | Salt Creek Medical Technologies | 1987-03-23 |
| AMNIGLOVE & AMNICOT (K850758) | Go Medical Industries Pty. , Ltd. | 1985-04-15 |
| H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 (K834177) | Imm Enterprises , Ltd. | 1983-12-27 |
Track HGE automatically
Every clearance here is in the API, with alerts when new ones post.