PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

Electrosurgical, Cutting & Coagulation & Accessories

PLASMA SURGICAL LIMITED

The following data is part of a premarket notification filed by Plasma Surgical Limited with the FDA for Plasmajet Neutral Plasma Surgery System.

Pre-market Notification Details

• Device ID: K121977
• 510k Number: K121977
• Device Name: PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: PLASMA SURGICAL LIMITED 127 MILTON PARK Abingdon, Oxfordshire, GB Ox14 4sa
• Contact: Peter Gibson
• Correspondent: Peter Gibson; PLASMA SURGICAL LIMITED 127 MILTON PARK Abingdon, Oxfordshire, GB Ox14 4sa
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-05
• Decision Date: 2012-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M397PS102130NL0	K121977	000
M397PS102130ISIL0	K121977	000
M397PS102130ISIE0	K121977	000
M397PS102130ISHU0	K121977	000
M397PS102130ISGB0	K121977	000
M397PS102130ISFR0	K121977	000
M397PS102130ISFI0	K121977	000
M397PS102130ISES0	K121977	000
M397PS102130ISDK0	K121977	000
M397PS102130ISDE0	K121977	000
M397PS102130ISCZ0	K121977	000
M397PS102130ISCH0	K121977	000
M397PS102130ISCA0	K121977	000
M397PS102130ISBE0	K121977	000
M397PS102130ISAU0	K121977	000
M397PS102130ISAT0	K121977	000
M397PS102130ISAE0	K121977	000
M397PS102130IS0	K121977	000
M397PS102130ISIR0	K121977	000
M397PS102130ISIS0	K121977	000
M397PS102130KW0	K121977	000
M397PS102130JP0	K121977	000
M397PS102130IT0	K121977	000
M397PS102130ISZA0	K121977	000
M397PS102130ISUS0	K121977	000
M397PS102130ISTR0	K121977	000
M397PS102130ISSE0	K121977	000
M397PS102130ISSA0	K121977	000
M397PS102130ISRU0	K121977	000
M397PS102130ISRO0	K121977	000
M397PS102130ISPL0	K121977	000
M397PS102130ISNZ0	K121977	000
M397PS102130ISNO0	K121977	000
M397PS102130ISNL0	K121977	000
M397PS102130ISKW0	K121977	000
M397PS102130ISJP0	K121977	000
M397PS102130ISIT0	K121977	000
M397PS102130IR0	K121977	000
M397PS102130IL0	K121977	000
M397OSCG05120	K121977	000
M397OSCG0507H2	K121977	000
M397OSCG05072	K121977	000
M397LSCP0528H2	K121977	000
M397LSCP05280	K121977	000
M397LSCG0528H2	K121977	000
M397LSCG05280	K121977	000
M397HO280	K121977	000
M397GCDU280	K121977	000
M397GCDU120	K121977	000
M397GCDU070	K121977	000
M397OSCP0512H2	K121977	000
M397S2CDU7H0	K121977	000
M397S2CDU72	K121977	000
M397S2CDU28H2	K121977	000
M397S2CDU282	K121977	000
M397S2CDU12H0	K121977	000
M397OSCG0512H2	K121977	000
M397OSCP05070	K121977	000
M397PS102130IE0	K121977	000
M397PS102130HU0	K121977	000
M397PS102130GB0	K121977	000
M397PS102130FR0	K121977	000
M397PS102130FI0	K121977	000
M397PS102130ES0	K121977	000
M397PS102130DK0	K121977	000
M397PS102130DE0	K121977	000
M397PS102130CZ0	K121977	000
M397PS102130CH0	K121977	000
M397PS102130CA0	K121977	000
M397PS102130BE0	K121977	000
M397PS102130AU0	K121977	000
M397PS102130AT0	K121977	000
M397PS102130AE0	K121977	000
M397OSCP05120	K121977	000
M397OSCP0507H2	K121977	000
M397S2CDU122	K121977	000
M397PS102130NO0	K121977	000
M397SCDU280	K121977	000
M397PS103130ISSE0	K121977	000
M397PS103130ISSA0	K121977	000
M397PS103130ISRU0	K121977	000
M397PS103130ISRO0	K121977	000
M397PS103130ISPL0	K121977	000
M397PS103130ISNZ0	K121977	000
M397PS103130ISNO0	K121977	000
M397PS103130ISNL0	K121977	000
M397PS103130ISKW0	K121977	000
M397PS103130ISJP0	K121977	000
M397PS103130ISIT0	K121977	000
M397PS103130ISIS0	K121977	000
M397PS103130ISIR0	K121977	000
M397PS103130ISIL0	K121977	000
M397PS103130ISIE0	K121977	000
M397PS103130ISHU0	K121977	000
M397PS103130ISGB0	K121977	000
M397PS103130ISTR0	K121977	000
M397PS103130ISUS0	K121977	000
M397SCDU120	K121977	000
M397SCDU070	K121977	000
M397PS103130ZA0	K121977	000
M397PS103130US0	K121977	000
M397PS103130TR0	K121977	000
M397PS103130SE0	K121977	000
M397PS103130SA0	K121977	000
M397PS103130RU0	K121977	000
M397PS103130RO0	K121977	000
M397PS103130PL0	K121977	000
M397PS103130NZ0	K121977	000
M397PS103130NO0	K121977	000
M397PS103130NL0	K121977	000
M397PS103130KW0	K121977	000
M397PS103130JP0	K121977	000
M397PS103130IT0	K121977	000
M397PS103130ISZA0	K121977	000
M397PS103130ISFR0	K121977	000
M397PS103130ISFI0	K121977	000
M397PS103130DK0	K121977	000
M397PS103130DE0	K121977	000
M397PS103130CZ0	K121977	000
M397PS103130CH0	K121977	000
M397PS103130CA0	K121977	000
M397PS103130BE0	K121977	000
M397PS103130AU0	K121977	000
M397PS103130AT0	K121977	000
M397PS103130AE0	K121977	000
M397PS102130ZA0	K121977	000
M397PS102130US0	K121977	000
M397PS102130TR0	K121977	000
M397PS102130SE0	K121977	000
M397PS102130SA0	K121977	000
M397PS102130RU0	K121977	000
M397PS102130RO0	K121977	000
M397PS102130PL0	K121977	000
M397PS103130ES0	K121977	000
M397PS103130FI0	K121977	000
M397PS103130ISES0	K121977	000
M397PS103130ISDK0	K121977	000
M397PS103130ISDE0	K121977	000
M397PS103130ISCZ0	K121977	000
M397PS103130ISCH0	K121977	000
M397PS103130ISCA0	K121977	000
M397PS103130ISBE0	K121977	000
M397PS103130ISAU0	K121977	000
M397PS103130ISAT0	K121977	000
M397PS103130ISAE0	K121977	000
M397PS103130IS0	K121977	000
M397PS103130IR0	K121977	000
M397PS103130IL0	K121977	000
M397PS103130IE0	K121977	000
M397PS103130HU0	K121977	000
M397PS103130GB0	K121977	000
M397PS103130FR0	K121977	000
M397PS102130NZ0	K121977	000