HGE · Class I · 21 CFR 884.4530

FDA Product Code HGE: Amniotome

Leading manufacturers include Imm Enterprises , Ltd., Epcom Medical Systems, Inc. and Raymart Development Co..

6
Total
6
Cleared
118d
Avg days
1983
Since

FDA 510(k) Cleared Amniotome Devices (Product Code HGE)

6 devices
1–6 of 6
Cleared Jun 09, 1995
OBSTI-HOOK
K951148
Onli
Obstetrics & Gynecology · 88d
Cleared Mar 07, 1994
AMNIPERF(TM)
K926425
Raymart Development Co.
Obstetrics & Gynecology · 439d
Cleared May 09, 1991
GLOVE-N-GEL AMNIOTOMY KIT
K910518
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 92d
Cleared Dec 27, 1983
H.R. JAKOBI SURG. INSTRUMENTS #4 30/31
K834177
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 36d

About Product Code HGE - Regulatory Context