Cleared Traditional

K963623 - SPYROFLEX PIGMENTED WOUND DRESSING

K963623 · Polymedica Industries, Inc. · General & Plastic Surgery device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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 76

Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K963623.

OPPORTUNITY I.V. START KIT

K971093 · Opportunity, Inc. · Sep 1997

ALGOPLAQUE HYDROCOLLOID DRESSING

K970518 · Laboratoires Urgo S.A. · Mar 1997

NASP TRANSPARENT DRESSING

K963753 · North American Sterilization & Packaging Co. · Nov 1996

EPIVIEW

K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996

BIO-DRESSING, STERILE ISLAND DRESSING

K961098 · K. W. Griffen Co. · May 1996

DERMASEAL

K960847 · Bellingham Medical, Inc. · Apr 1996

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K963623

Polymedica Industries, Inc.

Golden,, CO · US

ANDREW M REED

Regulatory profile

16 submissions 13 cleared

81% clearance rate · Active in General & Plastic Surgery

View all devices by Polymedica Industries, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 25, 1996. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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