Cleared Traditional

K150271 - Prime Adaptive Ultrasonic Scalpel System (FDA 510(k) Clearance)

K150271 · Endoprime, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
114d
Days
-
Risk

K150271 is an FDA 510(k) clearance for the Prime Adaptive Ultrasonic Scalpel System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Endoprime, Inc. (Blue Ash, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 114 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 Endoprime, Inc. devices

Submission Details

510(k) Number K150271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2015
Decision Date May 29, 2015
Days to Decision 114 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
At panel average
Panel avg: 114d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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