Cleared Traditional

K070309 - NEOSALUS

K070309 · Quinnova Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
589d
Days
-
Risk

K070309 is an FDA 510(k) clearance for the NEOSALUS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Quinnova Pharmaceuticals (Newtown, US). The FDA issued a Cleared decision on September 12, 2008 after a review of 589 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 - K070309

510(k) Number K070309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2007
Decision Date September 12, 2008
Days to Decision 589 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
474d slower than avg
Panel avg: 115d · This submission: 589d
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 668
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K070309.
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SILVERMED ANTIMICROBIAL SILVER HYDROGEL
K073019 · Argentis Biomedical Incorporated · Sep 2008
SILVER ANTIMICROBIAL WOUND GEL
K073197 · Advanced Medical Solutions Limited · Aug 2008
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
K080497 · Derma Sciences Canada, Inc. · Jun 2008
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876 · B.Braun Medical, Inc. · Jun 2008
K070309 · NEOSALUS
Download PDF FDA Summary Quinnova Pharmaceutic…