Cleared Traditional

MEDI-SURE, MEDI-SORB (K897180) - FDA 510(k) Clearance

K897180 · Gulf Coast Medical, Inc. · General & Plastic Surgery device
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Aug 1990
Decision
216d
Days
-
Risk

K897180 is an FDA 510(k) clearance for the MEDI-SURE, MEDI-SORB. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Gulf Coast Medical, Inc. (Oldsmar, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 216 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gulf Coast Medical, Inc. devices

Submission Details

510(k) Number K897180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1989
Decision Date August 01, 1990
Days to Decision 216 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K897180.
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982