Cleared Traditional

K083024 - HYLATOPIC EMOLLIENT FOAM

K083024 · Collegium Pharmaceutical Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
169d
Days
-
Risk

K083024 is an FDA 510(k) clearance for the HYLATOPIC EMOLLIENT FOAM. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Collegium Pharmaceutical Incorporated (Cumberland, US). The FDA issued a Cleared decision on March 27, 2009 after a review of 169 days - an extended review cycle.

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. Standard predicate reliance. 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.

View all Collegium Pharmaceutical Incorporated devices

FDA 510(k) Submission Details - K083024

510(k) Number K083024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date March 27, 2009
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 51
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K083024.
TENDERWET ACTIVE
K040517 · Medline Industries, Inc. · Mar 2004
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · Medtrade Products , Ltd. · Aug 2003
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
K013525 · Coloplast Corp. · Oct 2002
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc. · May 2001
GLUCANPRO CREAM
K002077 · Brennen Medical, Inc. · Oct 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · Brennen Medical, Inc. · Oct 2000