Cleared Traditional

K791736 - MEROCEL INSTRUMENT WIPE

K791736 is the FDA 510(k) clearance for MEROCEL INSTRUMENT WIPE by Xomed, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEC) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K791736 · Xomed, Inc. · General & Plastic Surgery device
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Sep 1979
Decision
19d
Days
Class 1
Risk

K791736 is an FDA 510(k) clearance for the MEROCEL INSTRUMENT WIPE. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xomed, Inc. devices

Submission Details

510(k) Number K791736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1979
Decision Date September 19, 1979
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEC Brush, Scrub, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GEC Brush, Scrub, Operating-room

All 17
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K791736.
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K791950 · Dexide, Inc. · Oct 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K791951 · Dexide, Inc. · Oct 1979
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH
K791952 · Dexide, Inc. · Oct 1979
BRUSH/SPONGE, DISPOSABLE
K782172 · Dexide, Inc. · Jan 1979
SURGERY BRUSH
K782173 · Dexide, Inc. · Jan 1979