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Spyrofilm Iq Wound Dressing(with Inert Filler)

by Polymedica Industries, Inc.

510(k) K932676

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

A comprehensive wound dressing designed to provide a barrier against bacteria and other contaminants, while also promoting healing and reducing the risk of infection. The device features an inert filler material that helps to slow down the release of antibiotics, allowing for more effective treatment.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932676 Date10 Dec 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRO
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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