510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K834343Substantially Equivalent

Comfeel Powder

MEDLINE INDUSTRIES, LP - Northfield, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834343 is the FDA 510(k) clearance record for COMFEEL POWDER, a class I device, cleared for Coloplast A/S on under FDA product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K834343.

Clearance record

Decision date
Received
(332 days to decision)
Product code
KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Regulation
21 CFR 878.4018
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Coloplast A/S 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KOZ

Trailing 12 months

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

FDA records show no clearances under product code KOZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOZ, 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