Data / Medical devices / United States / Sutter Medical Technologies USA Inc.
Sutter Medical Technologies USA Inc.: FDA-registered device maker in Alpharetta, GA, United States, 1 510(k) clearance
Sutter Medical Technologies USA Inc. is registered with the FDA (registration 3012940012) in Alpharetta, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 10, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012940012
- Address
- 3159 Royal Drive, Suite #340, Alpharetta, GA, United States, 30022
- Owner or operator
- Sutter Medizintechnik GmbH (9005453)
- Roles
- Repackager or relabeler
- First device listed
- February 5, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 10, 2013 | K123478 | STINGRAY BIPOLAR FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products | accessdata.fda.gov |
Compare with other makers
Updated May 10, 2013. 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.