ELASTO-GEL MANUKA HONEY WOUND DRESSING— 510(k) K083334

Name: FDA 510(k) clearance K083334
Creator: U.S. Food and Drug Administration
Published: 2009-07-30

Substantially Equivalent

Southwest Technologies, Inc.

FDA 510(k) clearance K083334 for ELASTO-GEL MANUKA HONEY WOUND DRESSING, Substantially Equivalent on 2009-07-30. Applicant: Southwest Technologies, Inc.. Device class: Unclassified.

Clearance details

Applicant: Southwest Technologies, Inc.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2008-11-12
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Southwest Technologies, Inc.

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K102478 — OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING2010-11-03
K030774 — STIMULEN COLLAGEN2004-08-09
K872488 — ELASTO-GEL CAST & SPLINT PADS1987-09-21
K872165 — ELASTO-GEL OCCLUSIVE DRESSING1987-06-26

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.