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.

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 76

Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K955383.

SURESKIN STANDARD

K960394 · Euromed A/S · Mar 1996

SURESKIN THIN

K960404 · Euromed A/S · Mar 1996

DUKAL TRANSPARENT WOUND DRESSING

K955476 · Dukal Corp. · Jan 1996

SPYROFLEX SKIN PROTECTOR

K953885 · Polymedica Industries, Inc. · Nov 1995

FLEXZAN WOUND DRESSING

K954602 · Dow Hickam Pharmaceuticals, Inc. · Nov 1995

DERMAGRAN HYDROPHILIC WOUND DRESSING

K954738 · Derma Sciences, Inc. · Nov 1995

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 K955383

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: December 13, 1995. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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