Cleared Traditional

K955383 - SPYROCOLLOID WOUND DRESSING

K955383 · Polymedica Industries, Inc. · General & Plastic Surgery device
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Dec 1995
Decision
19d
Days
-
Risk

K955383 is an FDA 510(k) clearance for the SPYROCOLLOID 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 December 13, 1995 after a review of 19 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 - K955383

510(k) Number K955383 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 24, 1995
Decision Date December 13, 1995
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K955383.
NASP TRANSPARENT DRESSING
K963753 · North American Sterilization & Packaging Co. · Nov 1996
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · Polymedica Industries, Inc. · Oct 1996
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
SPYROFLEX SKIN PROTECTOR
K953885 · Polymedica Industries, Inc. · Nov 1995
DERMAGRAN HYDROPHILIC WOUND DRESSING
K954738 · Derma Sciences, Inc. · Nov 1995
TECNOL ISLAND WOUND DRESSING
K954033 · Tecnol Medical Products, Inc. · Sep 1995