Cleared Traditional

K844702 - GAUZE ASORBABLE

K844702 · Medicon, Inc. · General & Plastic Surgery device
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Apr 1985
Decision
119d
Days
-
Risk

K844702 is an FDA 510(k) clearance for the GAUZE ASORBABLE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Medicon, Inc. (Norwalk, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K844702

510(k) Number K844702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1984
Decision Date April 01, 1985
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 269
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K844702.
APPLIED GAUZE SPONGE 3X3X12
K844675 · Applied Medical · Apr 1985
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K844676 · Applied Medical · Apr 1985
APPLIED GAUZE SPONGE 2X2X12
K844677 · Applied Medical · Apr 1985
GAUZE SPONGE 4X4X12 PLY
K844726 · Applied Medical · Apr 1985
ABSORBABLE GAUZE PRODUCTS
K844573 · Medicon, Inc. · Mar 1985
PANAMEDIC GAUZE SPONGES
K850093 · General Electric Trading Co. · Feb 1985
K844702 · GAUZE ASORBABLE
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