Cleared Traditional

K161358 - Medline ReNewal Reprocessed Stryker Nep...

K161358 is the FDA 510(k) clearance for Medline ReNewal Reprocessed Stryker Nep... by Surgical Instrument Service and Savings, Inc.. It is a Class 2 General & Plastic Surgery device (product code JCX) cleared through the Traditional 510(k) pathway after a 444-day FDA review.

K161358 · Surgical Instrument Service and Savings, Inc. · General & Plastic Surgery device
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Aug 2017
Decision
444d
Days
Class 2
Risk

K161358 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on August 3, 2017 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Surgical Instrument Service and Savings, Inc. devices

Submission Details

510(k) Number K161358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date August 03, 2017
Days to Decision 444 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
329d slower than avg
Panel avg: 115d · This submission: 444d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

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