Cleared Traditional

Ultrasonic Surgical Aspirator System (K202299) - FDA 510(k) Clearance

K202299 · Smtp Technology Co., Ltd. · General & Plastic Surgery device
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May 2021
Decision
281d
Days
-
Risk

K202299 is an FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Smtp Technology Co., Ltd. (Zhangjiagang, CN). The FDA issued a Cleared decision on May 21, 2021 after a review of 281 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 Smtp Technology Co., Ltd. devices

Submission Details

510(k) Number K202299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2020
Decision Date May 21, 2021
Days to Decision 281 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
166d slower than avg
Panel avg: 115d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

Emergo Global Consulting, LLC
Randy Jiang

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

All 53
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