Cleared Traditional

K181423 - AMSure Sterile Water

K181423 · Amsino International, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
99d
Days
-
Risk

K181423 is an FDA 510(k) clearance for the AMSure Sterile Water, and Sterile Normal Saline for Wound Flush. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on September 7, 2018 after a review of 99 days - within the typical 510(k) review window.

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 Amsino International, Inc. devices

Submission Details

510(k) Number K181423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2018
Decision Date September 07, 2018
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 211
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K181423.
Procellera Composite Antibacterial Wound Dressing
K180533 · Vomaris Wound Care, Inc. · Dec 2018
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
K182680 · Exciton Technologies, Inc. · Dec 2018
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
K180643 · Medcu Technologies , Ltd. · Nov 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
K181074 · Simple Science, LLC · Aug 2018
BIAFINE
K173549 · Valeant Pharmaceuticals · Aug 2018
Titan Ag 200
K173844 · Specialty Fibres and Materials, Ltd. · Aug 2018