FDA.reportPublic FDA data

PLASMA SURGICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047549833004754983PLASMA SURGICAL INC.1N2026-01-011125 Northmeadow Pkwy Ste 100 ROSWELL GA US 30076

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M397HO280Holster Option - Holster (Accessory) use for the Handpiece Holder6785784390cs@plasmasurgical.com
M397LSCP05280PlasmaJet Neutral Plasma Surgery System - Single-Use Cut/Coagulation Handpiece for the Laparoscopic Surgery for the PlasmaJet System6785784390cs@plasmasurgical.com
M397OSCG05120PlasmaJet Neutral Plasma Surgery System - Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System6785784390cs@plasmasurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
232872017069083K253917ARION ARC SystemGEI2026-04-10
232871617344286K121977PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMGEI2012-11-20
232871645302584K080197PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMGEI2008-06-24
232871272484299K030819PLASMAJET SYSTEMGEI2004-08-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI42026-04-10

PMN#

GUDID#

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