Cleared Traditional

K935257 - MEDICOM NON-WOVEN SPONGES

K935257 · A.R. Medicom, Inc. · General & Plastic Surgery device
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Apr 1994
Decision
164d
Days
-
Risk

K935257 is an FDA 510(k) clearance for the MEDICOM NON-WOVEN SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by A.R. Medicom, Inc. (Quebec, H4m 2n5 Canada, CA). The FDA issued a Cleared decision on April 14, 1994 after a review of 164 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 A.R. Medicom, Inc. devices

FDA 510(k) Submission Details - K935257

510(k) Number K935257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date April 14, 1994
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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