Cleared Traditional

K832214 - GAUZE CONVERSION CLASS I-NON-STERILE (FDA 510(k) Clearance)

K832214 · Winn Hirsch & Assoc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
14d
Days
-
Risk

K832214 is an FDA 510(k) clearance for the GAUZE CONVERSION CLASS I-NON-STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Winn Hirsch & Assoc. (Walker, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Winn Hirsch & Assoc. devices

Submission Details

510(k) Number K832214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1983
Decision Date July 26, 1983
Days to Decision 14 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
100d faster than avg
Panel avg: 114d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -