Cleared Traditional

K123193 - IPM WOUND GEL BIO

K123193 · Glycobiosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
508d
Days
-
Risk

K123193 is an FDA 510(k) clearance for the IPM WOUND GEL BIO. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Glycobiosciences, Inc. (Gergetown, Ontario, CA). The FDA issued a Cleared decision on March 3, 2014 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K123193

510(k) Number K123193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2012
Decision Date March 03, 2014
Days to Decision 508 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
393d slower than avg
Panel avg: 115d · This submission: 508d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K123193.
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
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CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
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L.A.M. IPM WOUND GEL, IPM DERM GEL
K130781 · Glycobiosciences, Inc. · Feb 2014
MEPITEL AG
K130040 · Molnlycke Health Care · Feb 2014
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
K130670 · Hydrofera, LLC · Jan 2014