Cleared Traditional

K913575 - GAUZE PACKING, SURGICAL STERILE AND NON-STERILE

K913575 · Keilei Intl., Inc. · General & Plastic Surgery device
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Sep 1991
Decision
25d
Days
-
Risk

K913575 is an FDA 510(k) clearance for the GAUZE PACKING, SURGICAL STERILE AND NON-STERILE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Keilei Intl., Inc. (Dover, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Keilei Intl., Inc. devices

FDA 510(k) Submission Details - K913575

510(k) Number K913575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date September 06, 1991
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 597
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K913575.
SALINE WET DRESSING- STERILE
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DERMAGRAN WOUND DRESSING
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INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990