K212614 - Ultrasonic Scalpel System (FDA 510(k) Clearance)

K212614 is an FDA 510(k) clearance for the Ultrasonic Scalpel System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on July 18, 2022 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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