Cleared Traditional

AMSure® Single Use Saline Topical Solution (K201138) - FDA 510(k) Clearance

K201138 · Amsino Medical, Inc. · General & Plastic Surgery device
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Apr 2021
Decision
351d
Days
-
Risk

K201138 is an FDA 510(k) clearance for the AMSure® Single Use Saline Topical Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Amsino Medical, Inc. (Aurora, US). The FDA issued a Cleared decision on April 14, 2021 after a review of 351 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.

View all Amsino Medical, Inc. devices

Submission Details

510(k) Number K201138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2020
Decision Date April 14, 2021
Days to Decision 351 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
236d slower than avg
Panel avg: 115d · This submission: 351d
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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