Cleared Traditional

HYDRASORB STERILE DRESSING (K931599) - FDA 510(k) Clearance

K931599 · Calgon Vestal Div. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
98d
Days
-
Risk

K931599 is an FDA 510(k) clearance for the HYDRASORB STERILE DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 98 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.

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Submission Details

510(k) Number K931599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date July 08, 1993
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -