Cleared Traditional

K233036 - Ultrasonic Surgical System (FDA 510(k) Clearance)

K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
267d
Days
-
Risk

K233036 is an FDA 510(k) clearance for the Ultrasonic Surgical System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Hunan Handlike Minimally Invasive Surgery Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on June 18, 2024 after a review of 267 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 Hunan Handlike Minimally Invasive Surgery Co., Ltd. devices

Submission Details

510(k) Number K233036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date June 18, 2024
Days to Decision 267 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
153d slower than avg
Panel avg: 114d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

Share Info (Guangzhou) Medical Consultant , Ltd.
Lee Cassie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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