Cleared Traditional

Ultrasonic Surgical System

K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · General & Plastic Surgery
Jun 2024
Decision
267d
Days
Risk

About This 510(k) Submission

K233036 is an FDA 510(k) clearance for the Ultrasonic Surgical System, a Instrument, Ultrasonic Surgical, submitted by Hunan Handlike Minimally Invasive Surgery Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on June 18, 2024, 267 days after receiving the submission on September 25, 2023. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K233036 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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