Data / Medical devices / United States / Soniquence, LLC
Soniquence, LLC: FDA-registered device maker in Baldwin, NY, United States, 8 510(k) clearances
Soniquence, LLC is registered with the FDA (registration 3014982808) in Baldwin, NY, United States. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated January 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014982808
- Address
- 2477 Grand Avenue, Baldwin, NY, United States, 11510
- Owner or operator
- Soniquence, LLC (10060579)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 29, 2019
- Registered through
- 2026
- Brand names listed
- 3 Button Fingerswitch Wand, Disposable Electrodes, Reusable Bipolar Cable, Reusable Bipolar Forceps, Reusable Handpiece, Reusable Neutral Plate, Soniquence Bipolar Wands, Soniquence RF Generator, and Monopolar Tips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 27, 2026 | K254220 | Reusable 3 Button Fingerswitch Wand | GEI | Substantially Equivalent | Soniquence, LLC | accessdata.fda.gov |
| September 2, 2022 | K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | GEI | Substantially Equivalent | Soniquence, LLC | accessdata.fda.gov |
| February 3, 2022 | K220071 | Soniquence Reusable Neutral Plate | GEI | Substantially Equivalent | Soniquence, LLC | accessdata.fda.gov |
| July 16, 2021 | K211946 | Soniquence Reusable Bipolar Cable | GEI | Substantially Equivalent | Soniquence, LLC | accessdata.fda.gov |
| June 20, 2019 | K190336 | Soniquence Bipolar Electrodes | GEI | Substantially Equivalent | Soniquence, LLC | accessdata.fda.gov |
| May 22, 2019 | K183611 | Soniquence RF Generator and Soniquence Electrodes | GEI | Substantially Equivalent | Soniquence, LLC | accessdata.fda.gov |
| October 19, 2000 | K002257 | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | GEI | Substantially Equivalent | Tecno Instruments (Pvt.) , Ltd. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.