Cleared Traditional

K896085 - SURGI-BRUSH

K896085 is an FDA 510(k) clearance for SURGI-BRUSH, manufactured by Sparta Surgical Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K896085 · Sparta Surgical Corp. · General & Plastic Surgery device
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Nov 1989
Decision
20d
Days
Class 1
Risk

K896085 is an FDA 510(k) clearance for the SURGI-BRUSH. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Sparta Surgical Corp. (Hayward, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 20 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.

FDA 510(k) Submission Details - K896085

510(k) Number K896085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date November 08, 1989
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

GEC Device Classification - Class 1, General Controls

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 25
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K896085.
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
K971473 · M-Pact Worldwide Management Corp. · Jul 1997
EXPANDACELL INSTRUMENT WIPE
K960621 · Shippert Medical Technologies Corp. · Apr 1996
BIODYNE INSTRUMENT WIPES
K900691 · Bio-Dyne, Inc. · Mar 1990
STERILE SCRUBBY SCRUB BRUSH
K875033 · Medsurg Industries, Inc. · Feb 1988
STERILE SURGICAL SCRUB BRUSH
K874653 · Surgikos, Inc. · Dec 1987
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
K854232 · American Pharmaseal Div. Ahsc · Dec 1985
K896085 · SURGI-BRUSH
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