Cleared Traditional

K123910 - WOUNDWASH SALINE SPRAY

K123910 · Neilmed Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
314d
Days
-
Risk

K123910 is an FDA 510(k) clearance for the WOUNDWASH SALINE SPRAY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Neilmed Pharmaceuticals, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on October 29, 2013 after a review of 314 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 - K123910

510(k) Number K123910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date October 29, 2013
Days to Decision 314 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
199d slower than avg
Panel avg: 115d · This submission: 314d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K123910 · WOUNDWASH SALINE SPRAY
Download PDF FDA Summary Neilmed Pharmaceutica…