Cleared Traditional

Saline Wound Wash, SteriCleanse(TM) (K183662) - FDA 510(k) Clearance

K183662 · Ascent Consumer Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
259d
Days
-
Risk

K183662 is an FDA 510(k) clearance for the Saline Wound Wash, SteriCleanse(TM). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ascent Consumer Products, Inc. (Melville, US). The FDA issued a Cleared decision on September 12, 2019 after a review of 259 days - an extended review 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: 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 Ascent Consumer Products, Inc. devices

Submission Details

510(k) Number K183662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date September 12, 2019
Days to Decision 259 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
144d slower than avg
Panel avg: 115d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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