Cleared Traditional

K952071 - ULTEC THIN HYDROCOLLOID DRESSING (FDA 510(k) Clearance)

K952071 · Sherwood Medical Co. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
51d
Days
-
Risk

K952071 is an FDA 510(k) clearance for the ULTEC THIN HYDROCOLLOID DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 51 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K952071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1995
Decision Date June 22, 1995
Days to Decision 51 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
63d faster than avg
Panel avg: 114d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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