Glove-N-Gel Amniotomy Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K910518 ↗

FDA Product Code

HGE

Device Class

Class I

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESK Substantially Equivalent — Kit

• Cervicath

  Class II

  FDA 510(k) K881414 Active Cleared 14 Jun 1988

• Urostresstik Diagnostic Cystometry Pack

  Class II

  FDA 510(k) K844503 Active Cleared 2 Jan 1985

• Epcom Ems-310 Intrapartum Monitor

  Class II

  FDA 510(k) K831113 Active Cleared 12 Aug 1983

• Epcom Ems-180 Antepartum Fetal Monitor

  Class II

  FDA 510(k) K813007 Active Cleared 10 Dec 1981

• Intrauterine Catheter Set

  Class II

  FDA 510(k) K905812 Active Cleared 31 Jan 1991

• Epcom Ems-330 Freedom I Teledop Obstet

  Class II

  FDA 510(k) K831114 Active Cleared 12 Aug 1983

See all devices from Epcom Medical Systems, Inc. →