Data / Medical devices / United States / Plasma Surgical Inc.
Plasma Surgical Inc.: FDA-registered device maker in Roswell, GA, United States, 2 510(k) clearances
Plasma Surgical Inc. is registered with the FDA (registration 3004754983) in Roswell, GA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 10, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004754983
- Address
- 1125 Northmeadow Pkwy Ste 100, Roswell, GA, United States, 30076
- Owner or operator
- PLASMA SURGICAL INC (9066219)
- Roles
- Manufacturer
- First device listed
- December 17, 2012
- Registered through
- 2026
- Brand names listed
- ArION ARC, PlasmaJet, PlasmaJet Ultra+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 10, 2026 | K253917 | ARION ARC System | GEI | Substantially Equivalent | Plasma Surgical, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121977 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | GEI | Substantially Equivalent | Plasma Surgical Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2012 | 61951 | Class II | Terminated | PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic | Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use. | accessdata.fda.gov |
Compare with other makers
Updated April 10, 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.