Cleared Traditional

K952071 - ULTEC THIN HYDROCOLLOID DRESSING

K952071 · Sherwood Medical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K952071

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K952071.
TECNOL ISLAND WOUND DRESSING
K954033 · Tecnol Medical Products, Inc. · Sep 1995
SPYROFLEX WOUND DRESSING
K953618 · Polymedica Industries, Inc. · Aug 1995
TECNOL TRANSPARENT WOUND DRESSING
K952504 · Tecnol Medical Products, Inc. · Jul 1995
MITRAFLEX WOUND DRESSING WET-STICK
K952217 · Polymedica Industries, Inc. · Jun 1995
CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING
K945977 · Tri-State Hospital Supply Corp. · Mar 1995
CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
K946338 · Certified Safety Mfg., Inc. · Mar 1995