510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092086Substantially Equivalent

Amerigel Wound Dressing Plus 1/2 Oz. (15G Tube), Model A2025; 1 Oz. (30G Tube), Model A2026; 3 Oz (90G Tube),model A2027

Amerx Health Care Corp., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092086 is the FDA 510(k) clearance record for AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027, cleared for Amerx Health Care Corp. on under FDA product code SEJ (Wound Dressings Containing Topical Analgesics). FDA's definition for product code SEJ reads: "A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or...". FDA records list 3 510(k) clearances for Amerx Health Care Corp., from to . As of , FDA records show no recalls naming K092086.

Clearance record

Decision date
Received
(21 days to decision)
Product code
SEJ Wound Dressings Containing Topical Analgesics
Device class
Unclassified
Review panel
Unknown
Applicant
Amerx Health Care Corp. 1300 S. Highland Ave., Clearwater FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SEJ

Trailing 12 months

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

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