Cleared Traditional

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

K210567 · Miconvey Technologies Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2022
Decision
581d
Days
-
Risk

K210567 is an FDA 510(k) clearance for the Ultrasonic Surgical System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Miconvey Technologies Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on September 30, 2022 after a review of 581 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Miconvey Technologies Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
467d slower than avg
Panel avg: 114d · This submission: 581d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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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