Cleared Traditional

K983065 - MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM

K983065 · Mentor Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
90d
Days
-
Risk

K983065 is an FDA 510(k) clearance for the MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 1, 1998 after a review of 90 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 Mentor Corp. devices

FDA 510(k) Submission Details - K983065

510(k) Number K983065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date December 01, 1998
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 139
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SONOTOME
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ULTRACISION 5MM INSTRUMENTS
K983316 · Ethicon Endo-Surgery, Inc. · Oct 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
K980930 · Fibra Sonics, Inc. · Sep 1998