Cleared Traditional

K953072 - MEROCEL VAGINAL PACK (FDA 510(k) Clearance)

K953072 · Merocel Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
74d
Days
-
Risk

K953072 is an FDA 510(k) clearance for the MEROCEL VAGINAL PACK. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Merocel Corp. (Jacksonville, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 74 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 Merocel Corp. devices

Submission Details

510(k) Number K953072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1995
Decision Date September 12, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 114d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -