Cleared Traditional

K210567 - Ultrasonic Surgical System (FDA 510(k) Clearance)

Sep 2022
Decision
581d
Days
-
Risk

K210567 is an FDA 510(k) clearance for the Ultrasonic Surgical System. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Miconvey Technologies Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on September 30, 2022, 581 days after receiving the submission on February 26, 2021.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K210567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2021
Decision Date September 30, 2022
Days to Decision 581 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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