Cleared Traditional

K172486 - Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle

K172486 · Anexa Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
35d
Days
-
Risk

K172486 is an FDA 510(k) clearance for the Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sod.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Anexa Biomedical, Inc. (Zephyrhills, US). The FDA issued a Cleared decision on September 21, 2017 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K172486

510(k) Number K172486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2017
Decision Date September 21, 2017
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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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