Cleared Traditional

K897180 - MEDI-SURE, MEDI-SORB

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

FDA 510(k) Submission Details - K897180

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.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K897180.
DYNAREX GAUZE SPONGE OR PADS
K933308 · Dynarex Corp. · Dec 1993
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · Johnson & Johnson Medical, Inc. · Sep 1992
PTI INTRA-ART (TM) PICK-UP WICKS
K905068 · Pioneering Technologies, Inc. · Dec 1991
SERENE WRAP
K895865 · Byron Medical · Dec 1989
LAP SPONGE
K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1989