Cleared Traditional

K161165 - Next Science Irrigation Solution (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161165 · Next Science, LLC · General & Plastic Surgery device
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Sep 2016
Decision
135d
Days
Class 2
Risk

K161165 is an FDA 510(k) clearance for the Next Science Irrigation Solution. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Next Science, LLC (Jacksonville, US). The FDA issued a Cleared decision on September 7, 2016 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5475 - the FDA general and plastic surgery device framework. 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 Next Science, LLC devices

Submission Details

510(k) Number K161165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date September 07, 2016
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 114d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 52
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K161165.
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