Modification of Bionect Clear Hydrogel

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K984264 ↗

FDA Product Code

MGQ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Bionect Hydrogel Foam

  Unclassified

  FDA 510(k) K973722 Active Cleared 22 Sep 1998

• Modification of Bionect Hydrogel Gauze Pads

  Unclassified

  FDA 510(k) K984262 Active Cleared 10 Feb 1999

• Modification of Bionect Hydrogel Spray

  Unclassified

  FDA 510(k) K984266 Active Cleared 10 Feb 1999

• Modification of Bionect Hydrogel Foam

  Unclassified

  FDA 510(k) K984267 Active Cleared 10 Feb 1999

• Bionect Hydrogel

  Unclassified

  FDA 510(k) K984413 Active Cleared 10 Feb 1999

• Bionect Hydrogel Gauze Pads

  Unclassified

  FDA 510(k) K973721 Active Cleared 22 Sep 1998

See all devices from Fidia Pharmaceutical Corp. →