Cleared Traditional

K910518 - GLOVE-N-GEL AMNIOTOMY KIT (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K910518 · Epcom Medical Systems, Inc. · Obstetrics & Gynecology device
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May 1991
Decision
92d
Days
Class 1
Risk

K910518 is an FDA 510(k) clearance for the GLOVE-N-GEL AMNIOTOMY KIT. Classified as Amniotome (product code HGE), Class I - General Controls.

Submitted by Epcom Medical Systems, Inc. (Livermore, US). The FDA issued a Cleared decision on May 9, 1991 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Epcom Medical Systems, Inc. devices

Submission Details

510(k) Number K910518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 06, 1991
Decision Date May 09, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 160d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HGE Amniotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.