Cleared Traditional

K160095 - Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz

K160095 · Simple Science, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
143d
Days
-
Risk

K160095 is an FDA 510(k) clearance for the Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimi.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Simple Science, LLC (Edina, US). The FDA issued a Cleared decision on June 10, 2016 after a review of 143 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 Simple Science, LLC devices

FDA 510(k) Submission Details - K160095

510(k) Number K160095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date June 10, 2016
Days to Decision 143 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 457
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K160095.
Atteris Antimicrobial Skin & Wound Cleanser
K160192 · Rochal Industries, LLC · Jul 2016
Dakin's Skin and Wound Cleanser
K150208 · Century Pharmaceuticals, Inc. · Jul 2016
Sorbact Foam Gentle Border, Sorbact Superabsorbent
K153674 · Abigo Medical AB · Jul 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
K152519 · Medical Technology Research, Inc. · Jun 2016
Agem Ag Mesh Dressing with Silver
K152544 · Shenzhen Yuanxing Nano-Pharma Co., Ltd. · May 2016
Dash-Topic Plus Cream
K150914 · Founders Science Group, LLC · Apr 2016