Cleared Traditional

K970153 - LAMIN-2 HYDRATING GEL

K970153 · Procyte Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1997
Decision
140d
Days
-
Risk

K970153 is an FDA 510(k) clearance for the LAMIN-2 HYDRATING GEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Procyte Corp. (Kirkland, US). The FDA issued a Cleared decision on June 5, 1997 after a review of 140 days - within the typical 510(k) review window.

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 Procyte Corp. devices

FDA 510(k) Submission Details - K970153

510(k) Number K970153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1997
Decision Date June 05, 1997
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 46
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K970153.
DUODERM HYDROACTIVE GEL
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AQUA PATCH
K973693 · Pci Technology · Dec 1997
AMERIGEL OINTMENT SATURATED WOUND DRESSING
K971918 · Amerx Health Care Corp. · Aug 1997
OSMOCYTE WOUND MANAGER SHEET DRESSING
K965143 · Procyte Corp. · May 1997
AMERIGEL OINTMENT
K970133 · Amerx Health Care Corp. · Apr 1997
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997