Cleared Traditional

K963623 - SPYROFLEX PIGMENTED WOUND DRESSING

K963623 · Polymedica Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
44d
Days
-
Risk

K963623 is an FDA 510(k) clearance for the SPYROFLEX PIGMENTED WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 44 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 - K963623

510(k) Number K963623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1996
Decision Date October 25, 1996
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 K963623.
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
K973036 · 3M Healthcare · Nov 1997
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
K964398 · Polymedica Industries, Inc. · Oct 1997
NASP TRANSPARENT DRESSING
K963753 · North American Sterilization & Packaging Co. · Nov 1996
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
SPYROCOLLOID WOUND DRESSING
K955383 · Polymedica Industries, Inc. · Dec 1995
SPYROFLEX SKIN PROTECTOR
K953885 · Polymedica Industries, Inc. · Nov 1995