Cleared Traditional

K030774 - STIMULEN COLLAGEN

K030774 · Southwest Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
517d
Days
-
Risk

K030774 is an FDA 510(k) clearance for the STIMULEN COLLAGEN. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Southwest Technologies, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 9, 2004 after a review of 517 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.

View all Southwest Technologies, Inc. devices

Submission Details

510(k) Number K030774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date August 09, 2004
Days to Decision 517 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
402d slower than avg
Panel avg: 115d · This submission: 517d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 85
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K030774.
INTEGRA WOUND MATRIX (THIN)
K113104 · Integra LifeSciences Corporation · Feb 2012
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006
COLLAGEN WOUND DRESSING - ORAL
K040403 · Collagen Matrix, Inc. · May 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · Collagen Matrix, Inc. · Mar 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · Collagen Matrix, Inc. · Feb 2004