510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K013525Substantially Equivalent

Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 Cm X 10Cm), 9613 (6X6 (15Cm X 15Cm)

MEDLINE INDUSTRIES, LP - Northfield, North Mankato MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013525 is the FDA 510(k) clearance record for CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM), cleared for Coloplast Corp. on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K013525.

Clearance record

Decision date
Received
(346 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
Coloplast Corp. 1940 Commerce Dr., North Mankato MN
510(k) summary
Summary
Third party review
No

Clearances, product code MGQ

Trailing 12 months

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

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