Cleared Traditional

K072904 - SONOCA 180/195 WOUND CARE SYSTEM

K072904 · Soering GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
223d
Days
-
Risk

K072904 is an FDA 510(k) clearance for the SONOCA 180/195 WOUND CARE SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Soering GmbH (Denton, US). The FDA issued a Cleared decision on May 21, 2008 after a review of 223 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 Soering GmbH devices

FDA 510(k) Submission Details - K072904

510(k) Number K072904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2007
Decision Date May 21, 2008
Days to Decision 223 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
108d slower than avg
Panel avg: 115d · This submission: 223d
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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