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510(k) K083334

ELASTO-GEL MANUKA HONEY WOUND DRESSING by Southwest Technologies, Inc. — Product Code FRO

K083334 is an FDA 510(k) premarket notification submitted by Southwest Technologies, Inc. for the device "ELASTO-GEL MANUKA HONEY WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on July 30, 2009. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Southwest Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
November 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Southwest Technologies, Inc.

  • K102478 — OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (November 3, 2010)
  • K030774 — STIMULEN COLLAGEN (August 9, 2004)
  • K872488 — ELASTO-GEL CAST & SPLINT PADS (September 21, 1987)
  • K872165 — ELASTO-GEL OCCLUSIVE DRESSING (June 26, 1987)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources