Cleared Traditional

K810655 - DISPOSABLE SCRUB BRUSH

K810655 is the FDA 510(k) clearance for DISPOSABLE SCRUB BRUSH by Dexide, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEC) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K810655 · Dexide, Inc. · General & Plastic Surgery device
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May 1981
Decision
63d
Days
Class 1
Risk

K810655 is an FDA 510(k) clearance for the DISPOSABLE SCRUB BRUSH. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Dexide, Inc. (Walker, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 63 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 K810655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date May 05, 1981
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 K810655.
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
K854232 · American Pharmaseal Div. Ahsc · Dec 1985
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · American Sterilizer Co. · Dec 1984
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · The Kendal Co. · Jan 1982
HEAVY DRAINAGE PACK
K803116 · American Medical Disposable, Inc. · Jan 1981
ANAGO ELECTRO SURGICAL TIP CLEANER
K800058 · Anago, Inc. · Jan 1980
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO
K792272 · Dexide, Inc. · Dec 1979