Cleared Traditional

K150936 - SureClip

K150936 is an FDA 510(k) clearance for SureClip, manufactured by Conmed Corporation. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K150936 · Conmed Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Oct 2015
Decision
199d
Days
Class 2
Risk

K150936 is an FDA 510(k) clearance for the SureClip. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on October 23, 2015 after a review of 199 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Conmed Corporation devices

FDA 510(k) Submission Details - K150936

510(k) Number K150936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2015
Decision Date October 23, 2015
Days to Decision 199 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
84d slower than avg
Panel avg: 115d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 104
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K150936.
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Premium Surgiclip¿
K143644 · Covidien · Sep 2015
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K150840 · Ethicon Endo-Surgery, LLC · Sep 2015
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K152081 · Teleflexmedical, Inc. · Aug 2015