Cleared Traditional

K960621 - EXPANDACELL INSTRUMENT WIPE

K960621 is an FDA 510(k) clearance for EXPANDACELL INSTRUMENT WIPE, manufactured by Shippert Medical Technologies Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K960621 · Shippert Medical Technologies Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
48d
Days
Class 1
Risk

K960621 is an FDA 510(k) clearance for the EXPANDACELL INSTRUMENT WIPE. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Shippert Medical Technologies Corp. (Englewood, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 48 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 Shippert Medical Technologies Corp. devices

FDA 510(k) Submission Details - K960621

510(k) Number K960621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date April 01, 1996
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
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 18
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K960621.
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
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · American Sterilizer Co. · Dec 1984
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · The Kendal Co. · Jan 1982
DISPOSABLE SCRUB BRUSH
K810655 · Dexide, Inc. · May 1981