Cleared Traditional

K972148 - B.U.S. ENDOTRON

K972148 · Medicamat S.A. · General & Plastic Surgery device
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Dec 1997
Decision
184d
Days
-
Risk

K972148 is an FDA 510(k) clearance for the B.U.S. ENDOTRON. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Medicamat S.A. (Washington, US). The FDA issued a Cleared decision on December 10, 1997 after a review of 184 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 Medicamat S.A. devices

FDA 510(k) Submission Details - K972148

510(k) Number K972148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date December 10, 1997
Days to Decision 184 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
69d slower than avg
Panel avg: 115d · This submission: 184d
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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SCULPTURE
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