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510(k) K102478

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

K102478 is an FDA 510(k) premarket notification submitted by Southwest Technologies, Inc. for the device "OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on November 3, 2010. 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
November 3, 2010
Date Received
August 30, 2010
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.

  • K083334 — ELASTO-GEL MANUKA HONEY WOUND DRESSING (July 30, 2009)
  • 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