Cleared Traditional

K942095 - SONOCA III

K942095 · Holl Meditronics, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
203d
Days
-
Risk

K942095 is an FDA 510(k) clearance for the SONOCA III. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Holl Meditronics, Inc. (Bolton, Ontario, CA). The FDA issued a Cleared decision on November 9, 1994 after a review of 203 days - an extended review cycle.

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 Holl Meditronics, Inc. devices

FDA 510(k) Submission Details - K942095

510(k) Number K942095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1994
Decision Date November 09, 1994
Days to Decision 203 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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