Cleared Traditional

K130781 - L.A.M. IPM WOUND GEL, IPM DERM GEL

K130781 · Glycobiosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
330d
Days
-
Risk

K130781 is an FDA 510(k) clearance for the L.A.M. IPM WOUND GEL, IPM DERM GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Glycobiosciences, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on February 14, 2014 after a review of 330 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130781

510(k) Number K130781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2013
Decision Date February 14, 2014
Days to Decision 330 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
215d slower than avg
Panel avg: 115d · This submission: 330d
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 K130781.
MANUKA FILL WOUND DRESSING
K131796 · Links Medical Products, Inc. · Mar 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
K133764 · Avery Dennison Belgie Bvba · Mar 2014
IPM WOUND GEL BIO
K123193 · Glycobiosciences, Inc. · Mar 2014
MEPITEL AG
K130040 · Molnlycke Health Care · Feb 2014
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
K130670 · Hydrofera, LLC · Jan 2014
NIVATOPIC PLUS
K132329 · Nivagen Pharmaceuticals, Inc. · Dec 2013