L.A.M. IMP WOUND GEL— 510(k) K123113

Name: FDA 510(k) clearance K123113
Creator: U.S. Food and Drug Administration
Published: 2012-12-11

Substantially Equivalent

Glycobiosciences, Inc.

FDA 510(k) clearance K123113 for L.A.M. IMP WOUND GEL, Substantially Equivalent on 2012-12-11. Applicant: Glycobiosciences, Inc.. Device class: Unclassified.

Clearance details

Applicant: Glycobiosciences, Inc.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-10-03
Decision date: 2012-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Glycobiosciences, Inc.

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K143527 — IPM Wound Gel Bio, IPM Derm Gel Bio2015-04-20
K123193 — IPM WOUND GEL BIO2014-03-03
K130781 — L.A.M. IPM WOUND GEL, IPM DERM GEL2014-02-14

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 →

Recalls naming K123113

K-number listed on FDA's recall record

Z-2112-2014 — IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.Class I·Terminated·Wellspring Pharmaceutical Corporation·20140325

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123113.

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