SPYROFLEX WOUND DRESSING— 510(k) K953618

Name: FDA 510(k) clearance K953618
Creator: U.S. Food and Drug Administration
Published: 1995-08-21

Substantially Equivalent for Some Indications

Polymedica Industries, Inc.

FDA 510(k) clearance K953618 for SPYROFLEX WOUND DRESSING, Substantially Equivalent for Some Indications on 1995-08-21. Applicant: Polymedica Industries, Inc.. Device class: Unclassified.

Clearance details

Applicant: Polymedica Industries, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-08-03
Decision date: 1995-08-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Golden,, CO, US

Download summary PDF View on FDA.gov ↗

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K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

More clearances from Polymedica Industries, Inc.

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K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED1997-10-24
K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER1997-05-02
K964701 — MITRAFLEX PIGMENTED WOUND DRESSING1997-02-07
K963623 — SPYROFLEX PIGMENTED WOUND DRESSING1996-10-25
K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER1996-09-12

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.