K241700 - Tenex 2nd Generation System (FDA 510(k) Clearance)

K241700 is an FDA 510(k) clearance for the Tenex 2nd Generation System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Trice Medical, Inc. (Malvern, US). The FDA issued a Cleared decision on November 18, 2024 after a review of 158 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.

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