Plasma Surgical Inc.
Roswell, GA, US
PLASMA SURGICAL INC. appears in FDA device records in Roswell, GA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Plasma Surgical Inc. between 2004 and 2026. The busiest year on record is 2004, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253917 | ARION ARC System | GEI | Substantially Equivalent | |
| K121977 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | GEI | Substantially Equivalent | |
| K080197 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | GEI | Substantially Equivalent | |
| K030819 | PLASMAJET SYSTEM | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004754983 | 3004754983 | PLASMA SURGICAL INC. | 1125 Northmeadow Pkwy Ste 100, ROSWELL, GA 30076 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1794-2012 | 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 surgery. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain