Cleared Traditional

SORING GMBH SONOCA 180/190 (K012753) - FDA 510(k) Clearance

K012753 · Soring GmbH Medizintechnik · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
89d
Days
-
Risk

K012753 is an FDA 510(k) clearance for the SORING GMBH SONOCA 180/190. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Soring GmbH Medizintechnik (Denton, US). The FDA issued a Cleared decision on November 13, 2001 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Soring GmbH Medizintechnik devices

Submission Details

510(k) Number K012753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date November 13, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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