FDA Product Code
FDA Product Code HGE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K951148 | OBSTI-HOOK | Onli | 1995-06-09 | Traditional | PDF ↗ |
| K926425 | AMNIPERF(TM) | Raymart Development Co. | 1994-03-07 | Traditional | PDF ↗ |
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | Epcom Medical Systems, Inc. | 1991-05-09 | Traditional | PDF ↗ |
| K871087 | S.C.M.T. PERFORATOR | Salt Creek Medical Technologies | 1987-03-23 | Traditional | PDF ↗ |
| K850758 | AMNIGLOVE & AMNICOT | Go Medical Industries Pty. , Ltd. | 1985-04-15 | Traditional | PDF ↗ |
| K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | Imm Enterprises , Ltd. | 1983-12-27 | Traditional | PDF ↗ |
Product code HGE · Class I · Obstetrics/Gynecology. Data: openFDA.