Cleared Traditional

K885142 - GAUZE SWABS

K885142 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Jan 1989
Decision
40d
Days
-
Risk

K885142 is an FDA 510(k) clearance for the GAUZE SWABS, NON-STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Smith & Nephew, Inc. (Miami, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 40 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K885142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1988
Decision Date January 24, 1989
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 23
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K885142.
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1989
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
K891460 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
ENVINET(TM)
K874551 · Marion Laboratories, Inc. · Jan 1988
PHARMANET (TM)
K872572 · Pharmacia, Inc. · Jan 1988