510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K111313Substantially Equivalent

Exsept Skin and Wound Cleanser with Antimicrobial Preservative

Alcavis Hdc, LLC, Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111313 is the FDA 510(k) clearance record for EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE, a class II device, cleared for Alcavis Hdc, LLC on under FDA product code FQH (Lavage, Jet). FDA records list one 510(k) clearance for Alcavis Hdc, LLC. As of , FDA records show no recalls naming K111313.

Clearance record

Decision date
Received
(218 days to decision)
Product code
FQH Lavage, Jet
Regulation
21 CFR 880.5475
Device class
Class II
Review panel
General Hospital
Applicant
Alcavis Hdc, LLC 8322 Helgerman Ct., Gaithersburg MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FQH

Trailing 12 months
2 clearances under product code FQH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260