Cleared Traditional

K844573 - ABSORBABLE GAUZE PRODUCTS (FDA 510(k) Clearance)

K844573 · Medicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
102d
Days
-
Risk

K844573 is an FDA 510(k) clearance for the ABSORBABLE GAUZE PRODUCTS. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Medicon, Inc. (Norwalk, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 102 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.

View all Medicon, Inc. devices

Submission Details

510(k) Number K844573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date March 05, 1985
Days to Decision 102 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
12d faster than avg
Panel avg: 114d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -