Cleared Traditional

K901974 - SELECTOR ULTRASONIC SURGICAL ASPIRATOR

K901974 · Spembly Medical , Ltd. · General & Plastic Surgery device
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Sep 1990
Decision
127d
Days
-
Risk

K901974 is an FDA 510(k) clearance for the SELECTOR ULTRASONIC SURGICAL ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Spembly Medical , Ltd. (England, GB). The FDA issued a Cleared decision on September 5, 1990 after a review of 127 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.

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Submission Details

510(k) Number K901974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date September 05, 1990
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 87
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K901974.
CV720-727-000, MICROTIP AND FLUE PAK
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CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
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SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · Sharplan Lasers, Inc. · Oct 1988
CUSA SYSTEM 200 MACRO-DISSECTOR
K864983 · Cooper Lasersonics, Inc. · Jun 1987