Cleared Traditional

K971473 - IVALON INSTRUMENT WIPE

K971473 is an FDA 510(k) clearance for IVALON INSTRUMENT WIPE, manufactured by M-Pact Worldwide Management Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K971473 · M-Pact Worldwide Management Corp. · General & Plastic Surgery device
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Jul 1997
Decision
75d
Days
Class 1
Risk

K971473 is an FDA 510(k) clearance for the IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by M-Pact Worldwide Management Corp. (Eudora, US). The FDA issued a Cleared decision on July 7, 1997 after a review of 75 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 M-Pact Worldwide Management Corp. devices

FDA 510(k) Submission Details - K971473

510(k) Number K971473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1997
Decision Date July 07, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
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 K971473.
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