Cleared Traditional

K952217 - MITRAFLEX WOUND DRESSING WET-STICK

K952217 · Polymedica Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
42d
Days
-
Risk

K952217 is an FDA 510(k) clearance for the MITRAFLEX WOUND DRESSING WET-STICK. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 42 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 Polymedica Industries, Inc. devices

FDA 510(k) Submission Details - K952217

510(k) Number K952217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1995
Decision Date June 22, 1995
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 28
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K952217.
SPYROFLEX WOUND DRESSING
K953618 · Polymedica Industries, Inc. · Aug 1995
TECNOL TRANSPARENT WOUND DRESSING
K952504 · Tecnol Medical Products, Inc. · Jul 1995
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · 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
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995