Amniotome
FDA product code HGE · Class I (low risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951148 | Obsti-HookHGE · Traditional | Onli | 06/09/1995SE |
| K926425 | Amniperf(Tm)HGE · Traditional | Raymart Development Co. | 03/07/1994SE |
| K910518 | Glove-N-Gel Amniotomy KitHGE · Traditional | Epcom Medical Systems, Inc. | 05/09/1991SESK |
| K871087 | S.C.M.T. PerforatorHGE · Traditional | Salt Creek Medical Technologies | 03/23/1987SE |
| K850758 | Amniglove & AmnicotHGE · Traditional | Go Medical Industries Pty. , Ltd. | 04/15/1985SE |
| K834177 | H.R. Jakobi Surg. Instruments #4 30/31HGE · Traditional | Imm Enterprises , Ltd. | 12/27/1983SE |