510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910518Unknown

Glove-N-Gel Amniotomy Kit

Epcom Medical Systems, Inc., Livermore CA / Traditional, Unknown
FDA source (opens on fda.gov)

K910518 is the FDA 510(k) clearance record for GLOVE-N-GEL AMNIOTOMY KIT, a class I device, cleared for Epcom Medical Systems, Inc. on under FDA product code HGE (Amniotome). FDA records list 13 510(k) clearances for Epcom Medical Systems, Inc., from to . As of , FDA records show no recalls naming K910518.

Clearance record

Decision date
Received
(92 days to decision)
Product code
HGE Amniotome
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Epcom Medical Systems, Inc. 302 Lindbergh Ave., Livermore CA
Third party review
No

Clearances, product code HGE

Trailing 12 months

FDA records hold no clearances under product code HGE in the trailing twelve months.

FDA records show no clearances under product code HGE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260