Cleared Traditional

K932700 - CUTO(TM) TISSUE MORCELLATION SYSTEM

K932700 is the FDA 510(k) clearance for CUTO(TM) TISSUE MORCELLATION SYSTEM by Linvatec Corp.. It is a Class 1 General & Plastic Surgery device (product code GEY) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K932700 · Linvatec Corp. · General & Plastic Surgery device
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Oct 1993
Decision
134d
Days
Class 1
Risk

K932700 is an FDA 510(k) clearance for the CUTO(TM) TISSUE MORCELLATION SYSTEM. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on October 15, 1993 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Linvatec Corp. devices

Submission Details

510(k) Number K932700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date October 15, 1993
Days to Decision 134 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Conmed Corporation
Keith M Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 17
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K932700.
KARL STORZ DRILL
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3M MAXI-DRIVER II ELECTRIC SYSTEM
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K940535 · The Anspach Effort, Inc. · Mar 1994
AESCULAP SURGICAL ACCESSORIES
K913262 · Aesculap, Inc. · Dec 1991
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033 · Micro-Aire Surgical Instruments, Inc. · Feb 1990
THE DEXTRA PRECISION POWER UNIT
K853778 · Storz Instrument Co. · Nov 1985