FDA.reportPublic FDA data

PlasmaJet Neutral Plasma Surgery System

Primary DI
M397OSCP0512H2
Brand
PlasmaJet Neutral Plasma Surgery System
Company
PLASMA SURGICAL, INC
Model
OS-CP 05-12H
Catalog number
OS-CP 05-12H
Device description
Single-use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
M397OSCP0512H2PackageHIBCC5In Commercial Distribution
M3970SCP0512H0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Plasma surgical system handpieceA hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 678 578 4390cs@plasmasurgical.com

Regulatory Flags#

DUNS number
360799048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
00848657078399AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
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