Cleared Special

Ultrasonic Surgical Aspirator System, Model: XD880B (K212750) - FDA 510(k) Clearance

K212750 · Smtp Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
28d
Days
-
Risk

K212750 is an FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System, Model: XD880B. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Smtp Technology Co., Ltd. (Zhangjiagang, CN). The FDA issued a Cleared decision on September 27, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smtp Technology Co., Ltd. devices

Submission Details

510(k) Number K212750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2021
Decision Date September 27, 2021
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 53
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K212750.
Sonopet iQ Ultrasonic Aspirator System
K213824 · Stryker Corporation · Feb 2022
neXus Ultrasonic Surgical Aspirator System
K212060 · Misonix, Inc. · Dec 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · Covidien, LLC · Nov 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838 · Olympus Medical Systems Corporation · Aug 2021
Ultrasonic Surgical Aspirator System
K202299 · Smtp Technology Co., Ltd. · May 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273 · Ethicon Endo-Surgery, LLC · May 2021