510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964398Substantially Equivalent

Spyroflex Pigmented Wound Dressing/spyroflex Wound Dressing Tinted

Polymedica Industries, Inc., Golden, CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964398 is the FDA 510(k) clearance record for SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED, cleared for Polymedica Industries, Inc. on under FDA product code MGP (Dressing, Wound And Burn, Occlusive). FDA records list 16 510(k) clearances for Polymedica Industries, Inc., from to . As of , FDA records show no recalls naming K964398.

Clearance record

Decision date
Received
(354 days to decision)
Product code
MGP Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Review panel
Unknown
Applicant
Polymedica Industries, Inc. 581 Conference Pl., Golden, CO
510(k) summary
Summary
Third party review
No

Clearances, product code MGP

Trailing 12 months

FDA records hold no clearances under product code MGP in the trailing twelve months.

FDA records show no clearances under product code MGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260