Cleared Traditional

K212301 - Sonicision 7 Curved Jaw Cordless Ultras...

K212301 · Covidien, LLC · General & Plastic Surgery device
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Nov 2021
Decision
115d
Days
-
Risk

K212301 is an FDA 510(k) clearance for the Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on November 15, 2021 after a review of 115 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 K212301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2021
Decision Date November 15, 2021
Days to Decision 115 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
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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