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

by Amerx Health Care Corp.

510(k) K092086

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092086 Date30 Jul 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
SEJ
Models / Variants
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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