510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113268Substantially Equivalent

Alexis O Wound Protector/retractor

Applied Medical Resources Corp, Rancho Santa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113268 is the FDA 510(k) clearance record for ALEXIS O WOUND PROTECTOR/RETRACTOR, a class II device, cleared for Applied Medical Resources Corp. on under FDA product code KGW (Ring (Wound Protector), Drape Retention, Internal). FDA records list 115 510(k) clearances for Applied Medical Resources Corp., from to . As of , FDA records show no recalls naming K113268.

Clearance record

Decision date
Received
(462 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
Applied Medical Resources Corp. 22872 Avenida Empresa, Rancho Santa CA
510(k) summary
Summary PDF
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