Cleared Traditional

K791950 - DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE

K791950 is the FDA 510(k) clearance for DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE by Dexide, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEC) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K791950 · Dexide, Inc. · General & Plastic Surgery device
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Oct 1979
Decision
16d
Days
Class 1
Risk

K791950 is an FDA 510(k) clearance for the DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Dexide, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 16 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 Dexide, Inc. devices

Submission Details

510(k) Number K791950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1979
Decision Date October 17, 1979
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 K791950.
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K792271 · Dexide, Inc. · Dec 1979
DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P
K792273 · Dexide, Inc. · Dec 1979
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH
K791949 · Dexide, Inc. · Oct 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K791951 · Dexide, Inc. · Oct 1979
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH
K791952 · Dexide, Inc. · Oct 1979
MEROCEL INSTRUMENT WIPE
K791736 · Xomed, Inc. · Sep 1979