FDA.reportPublic FDA data

PlasmaJet Neutral Plasma Surgery System

Primary DI
M397PS103130CZ0
Brand
PlasmaJet Neutral Plasma Surgery System
Company
PLASMA SURGICAL, INC
Model
PS10-3130-CZ
Catalog number
PS10-3130-CZ
Device description
PlasmaJet Ultra Plus Console System (Czech Republic)
Published
2018-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121977000PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMPlasma Surgical Limited2012-11-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M397PS103130CZ0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plasma surgical systemAn assembly of electrically-powered devices designed to generate a fine plasma jet used to coagulate, cut, and/or vaporize/ablate tissue and/or reduce inflammation/promote healing during open, laparoscopic or topical surgery. The system has a gas [e.g., argon (Ar)] supply or an ambient air input, and typically includes a control unit, a handpiece(s) with connection cable and foot-switch. The plasma [e.g., argon (Ar), nitric oxide] is generated in the handpiece and is applied to tissue where the surgical effect is achieved without passing electric current through the body.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6785784390cs@plasmasurgical.com

Regulatory Flags#

DUNS number
360799048
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M397PS102130PlasmaJet Neutral Plasma Surgery SystemPS10-2130PS10-21302026-05-06
M397PS103130PlasmaJet Neutral Plasma Surgery SystemPS10-3130PS10-31302026-05-06
M397PS104130ARIONPS10-4130PS10-41302026-05-06
M3970SCP0512H0PlasmaJet Neutral Plasma Surgery SystemOS-CP 05-12HOS-CP 05-12H2016-07-18
M397LSCG0528H0PlasmaJet Neutral Plasma Surgery SystemLS-CG 05-28HLS-CG 05-28H2016-07-18
M397LSCP0528H0PlasmaJet Neutral Plasma Surgery SystemLS-CP 05-28HLS-CP 05-28H2016-07-18
M397OSCG05070PlasmaJet Neutral Plasma Surgery SystemOS-CG-05-07OS-CG-05-072018-10-01
M397OSCG0507H0PlasmaJet Neutral Plasma Surgery SystemOS-CG 05-07HOS-CG 05-07H2016-07-18
M397OSCG0512H0PlasmaJet Neutral Plasma Surgery SystemOS-CG 05-12HOS-CG 05-12H2016-07-18
M397OSCP0507H0PlasmaJet Neutral Plasma Surgery SystemOS-CP 05-07HOS-CP 05-07H2016-07-18
M397HO280Holster OptionHO-28HO-282018-10-01
M397LSCP05280PlasmaJet Neutral Plasma Surgery SystemLS-CP-05-28LS-CP-05-282018-10-01
M397OSCG05120PlasmaJet Neutral Plasma Surgery SystemOS-CG-05-12OS-CG-05-122018-10-01
M397OSCP05070PlasmaJet Neutral Plasma Surgery SystemOS-CP-05-07OS-CP-05-072018-10-01
M397OSCP05120PlasmaJet Neutral Plasma Surgery SystemOS-CP-05-12OS-CP-05-122018-10-01
M397ARC1070ARIONARC-107ARC-1072026-04-28
M397ARCDK170ARIONARC-DK1-7ARC-DK1-72026-04-28
M397ARCSK170ARIONARC-SK1-7ARC-SK1-72026-04-28
M397PS102130AE0PlasmaJet Neutral Plasma Surgery SystemPS10-2130-AEPS10-2130-AE2018-10-01
M397PS102130AU0PlasmaJet Neutral Plasma Surgery SystemPS10-2130-AUPS10-2130-AU2018-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078399AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
00848657078405AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALGEI2026-07-10
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09