510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840946Substantially Equivalent

Microporous Hypoallergenic

Gainor Medical, US / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840946 is the FDA 510(k) clearance record for MICROPOROUS HYPOALLERGENIC, a class II device, cleared for Gainor Medical on under FDA product code KGW (Ring (Wound Protector), Drape Retention, Internal). FDA records list 11 510(k) clearances for Gainor Medical, from to . As of , FDA records show no recalls naming K840946.

Clearance record

Decision date
Received
(165 days to decision)
Product code
KGW Ring (Wound Protector), Drape Retention, Internal
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gainor Medical 12520 Yellowhead Trl., US
Third party review
No

Clearances, product code KGW

Trailing 12 months
2 clearances under product code KGW in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260