SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM— 510(k) K974520

Name: FDA 510(k) clearance K974520
Creator: U.S. Food and Drug Administration
Published: 1998-02-06

Substantially Equivalent

Innovative Technologies (Us), Inc.

FDA 510(k) clearance K974520 for SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM, Substantially Equivalent on 1998-02-06. Applicant: Innovative Technologies (Us), Inc.. Device class: Unclassified.

Clearance details

Applicant: Innovative Technologies (Us), Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-12-02
Decision date: 1998-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden,, CO, US

Download summary PDF View on FDA.gov ↗

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K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

More clearances from Innovative Technologies (Us), Inc.

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K982804 — SPYROGEL HYDROGEL WOUND AND BURN DRESSING1998-12-16
K980673 — SPYROSORB FOAM ISLAND WOUND DRESSING1998-05-21

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.