Cleared Traditional

DUKAL ABD COMBINE PAD (K970457) - FDA 510(k) Clearance

K970457 · Dukal Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
91d
Days
-
Risk

K970457 is an FDA 510(k) clearance for the DUKAL ABD COMBINE PAD. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dukal Corp. (Tarpon Springs, US). The FDA issued a Cleared decision on May 8, 1997 after a review of 91 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 Dukal Corp. devices

Submission Details

510(k) Number K970457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1997
Decision Date May 08, 1997
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -