Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015136673

FEI Number

3015136673

Entity Name

RF MEDICAL CO., LTD

City/State/Country

Seoul, KR

Establishment Address

#502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu, Seoul 08513, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RF MEDICAL CO., LTD (Owner Number: 10059293)

Owner / Operator Contact Address

#502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu, Seoul, KR-11 08513, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mygen M-3004 RF Generator BIG-TIP (BT 0640PB) BIG-TIP (BTW 2015B) BIG-TIP (CWT 1535RB) MYOBLATE (BTM 3520QB) MYOBLATE (BTM 3040RB) JET-TIP® (JET 1510B) JET-TIP® (JET 1530B) JET-TIP® (JET 3540XB) JET-TIP® (JET 2525B) THYBLATE (RFTP 07XXN) BIG-TIP (BT 2040B) BIG-TIP (CWT 3510RB) BIG-TIP (CWT 1520B) BIG-TIP (BT 0630B) BIG-TIP (BTW 1505B) BIG-TIP (BT 1035B) BIG-TIP (BTW 1520B) BIG-TIP (CWT 3520RB) MYOBLATE (BTM 3515RB) BIG-TIP (CWT 1520RB) BIG-TIP (CWT 2040RB) JET-TIP® (JET 2025XB) BIG-TIP (BTW 2035B) JET-TIP® (JET 2530B) MYOBLATE (BTM 2035QB) MYOBLATE (BTM 3025QB) JET-TIP® (JET 2005XB) JET-TIP® (JET 2020B) THYBLATE (RFTP 10XXHLN) JET-TIP® (JET 1505B) THYBLATE (RFT 10XXL) THYBLATE (RFTP 07XXHLN) BIG-TIP (BT 2525B) BIG-TIP (BT 1035OB) BIG-TIP (BT 2540B) BIG-TIP (CWT 2515RB) MYOBLATE (BTM 2005RB) JET-TIP® (JET 3030QB) JET-TIP® (JET 2520QB) JET-TIP® (JET 2040B) JET-TIP® (JET 3010QB) JET-TIP® (JET 2535QB) JET-TIP® (JET 3025B) THYBLATE (RFT 10XXHN) BIG-TIP (BTW 1530B) BIG-TIP (CWT 3515B) BIG-TIP (CWT 2015RB) MYOBLATE (BTM 3515QB) MYOBLATE (BTM 2540QB) JET-TIP® (JET 2540XB) JET-TIP® (JET 2505B) JET-TIP® (JET 2525QB) JET-TIP® (JET 2520B) JET-TIP® (JET 3515QB) THYBLATE (RFT 07XXHN) BIG-TIP (BT 0620PB) BIG-TIP (BT+ 2010B) BIG-TIP (CWT 3505RB) BIG-TIP (CWT 2010RB) MYOBLATE (BTM 3025RB) JET-TIP® (JET 3520XB) JET-TIP® (JET 2515B) JET-TIP® (JET 2035XB) JET-TIP® (JET 2520XB) JET-TIP® (JET 2030XB) JET-TIP® (JET 3030XB) BIG-TIP (BT 1010B) BIG-TIP (BT 2035B) BIG-TIP (CWT 2030B) BIG-TIP (BT+ 2515B) MYOBLATE (BTM 3030QB) MYOBLATE (BTM 2530RB) JET-TIP® (JET 1535XB) JET-TIP® (JET 2020XB) JET-TIP® (JET 3015QB) JET-TIP® (JET 3005XB) BIG-TIP (BT 1040OB) BIG-TIP (CWT 2525RB) BIG-TIP (CWT 2035RB) BIG-TIP (CWT 2015B) BIG-TIP (BT+ 2025B) MYOBLATE (BTM 3510QB) JET-TIP® (JET 3525QB) JET-TIP® (JET 3535XB) JET-TIP® (JET 2540QB) JET-TIP® (JET 1530XB) JET-TIP® (JET 2510B) THYBLATE (RFT 10XXHLN) BIG-TIP (BT 2030B) BIG-TIP (BTW 2030B) BIG-TIP (CWT 2020B) BIG-TIP (BT+ 2015B) MYOBLATE (BTM 2540RB) JET-TIP® (JET 2505QB) JET-TIP® (JET 1520QB) JET-TIP® (JET 2005B) THYBLATE (RFT 10XXLN) BIG-TIP (BT 0610B) BIG-TIP (BT 2005B) BIG-TIP (CWT 1515RB) BIG-TIP (CWT 2505RB) BIG-TIP (BT+ 2040B) MYOBLATE (BTM 2030QB) MYOBLATE (BTM 3005RB) JET-TIP® (JET 1020B) JET-TIP® (JET 3010XB) VARY-TIP (VCTU 12XXB) THYBLATE (RFTP 07XXHN) BIG-TIP (BT 1540B) BIG-TIP (BT 0605B) BIG-TIP (CWT 3540B) BIG-TIP (CWT 3520B) MYOBLATE (BTM 2535QB) MYOBLATE (BTM 3015QB) JET-TIP® (JET 2010B) JET-TIP® (JET 1540B) JET-TIP® (JET 2005QB) THYBLATE (RFT 07XXH) BIG-TIP (BT 1005B) BIG-TIP (BT+ 2035B) BIG-TIP (BT+ 2030B) BIG-TIP (BT+ 1535B) MYOBLATE (BTM 2525QB) JET-TIP® (JET 2530QB) JET-TIP® (JET 3540QB) JET-TIP® (JET 3005QB) THYBLATE (RFT 10XXHL) THYBLATE (RFT 07XXL) BIG-TIP (BT 0625PB) BIG-TIP (CWT 2020RB) BIG-TIP (CWT 1525RB) MYOBLATE (BTM 2525RB) JET-TIP® (JET 2015QB) JET-TIP® (JET 1505QB) JET-TIP® (JET 1040B) JET-TIP® (JET 3020XB) JET-TIP® (JET 3015XB) JET-TIP® (JET 0715TB) BIG-TIP (BT 2510B) BIG-TIP (BT 2020B) BIG-TIP (BT+ 2005B) BIG-TIP (CWT 2535B) BIG-TIP (CWT 2025RB) BIG-TIP (CWT 2025B) MYOBLATE (BTM 2515QB) MYOBLATE (BTM 3530QB) JET-TIP® (JET 1515QB) JET-TIP® (JET 1540XB) JET-TIP® (JET 2515QB) JET-TIP® (JET 2535B) THYBLATE (RFT 10XX) THYBLATE (RFTP 10XXHN) BIG-TIP (BT 0640B) BIG-TIP (BT 1530B) BIG-TIP (CWT 1535B) BIG-TIP (BTW 1510B) BIG-TIP (CWT 2535RB) MYOBLATE (BTM 3540RB) MYOBLATE (BTM 3030RB) MYOBLATE (BTM 2005QB) JET-TIP® (JET 3040QB) JET-TIP® (JET 3505XB) THYBLATE (RFTP 10XXN) BIG-TIP (BT 0615PB) BIG-TIP (BT 1030OB) BIG-TIP (BT+ 2505B) BIG-TIP (CWT 2515B) BIG-TIP (CWT 3525RB) MYOBLATE (BTM 2015RB) MYOBLATE (BTM 3020QB) JET-TIP® (JET 1525QB) JET-TIP® (JET 1515XB) JET-TIP® (JET 3025QB) THYBLATE (RFTP 10XXLN) BIG-TIP (BT 0635PB) BIG-TIP (BT 1525B) BIG-TIP (BT 0610PB) BIG-TIP (BT+ 1505B) MYOBLATE (BTM 2505QB) MYOBLATE (BTM 3035RB) MYOBLATE (BTM 3535RB) JET-TIP® (JET 3535QB) JET-TIP® (JET 2540B) JET-TIP® (JET 2035B) JET-TIP® (JET 3525XB) BIG-TIP (BT 1515B) BIG-TIP (BTW 1525B) MYOBLATE (BTM 3525QB) MYOBLATE (BTM 2025RB) JET-TIP® (JET 2025B) JET-TIP® (JET 3040B) JET-TIP® (JET 3035B) JET-TIP® (JET 2020QB) JET-TIP® (JET 3005B) BIG-TIP (BT 2520B) BIG-TIP (BT 1005OB) BIG-TIP (CWT 1525B) BIG-TIP (CWT 2030RB) MYOBLATE (BTM 3005QB) MYOBLATE (BTM 3520RB) JET-TIP® (JET 1025B) JET-TIP® (JET 3035XB) JET-TIP® (JET 1520B) JET-TIP® (JET 1515B) BIG-TIP (BT 2025B) BIG-TIP (CWT 2040B) BIG-TIP (BT+ 1530B) BIG-TIP (CWT 3535RB) BIG-TIP (CWT 2520B) MYOBLATE (BTM 2010QB) MYOBLATE (BTM 2530QB) JET-TIP® (JET 3510XB) JET-TIP® (JET 3020B) THYBLATE (RFTPS 07XXLN) BIG-TIP (BT 1025B) BIG-TIP (CWT 3510B) BIG-TIP (CWT 3530RB) MYOBLATE (BTM 2510RB) MYOBLATE (BTM 2520RB) JET-TIP® (JET 3040XB) JET-TIP® (JET 1035B) JET-TIP® (JET 3515XB) JET-TIP® (JET 3530QB) JET-TIP® (JET 1535B) BIG-TIP (BT 1015B) BIG-TIP (BT 1020B) BIG-TIP (CWT 2010B) BIG-TIP (BT+ 1525B) BIG-TIP (CWT 1510B) MYOBLATE (BTM 2035RB) MYOBLATE (BTM 3035QB) JET-TIP® (JET 2010XB) JET-TIP® (JET 1525XB) JET-TIP® (JET 2025QB) JET-TIP® (JET 1505XB) JET-TIP® (JET 1535QB) THYBLATE (RFTP 07XXHL) BIG-TIP (BT 2505B) BIG-TIP (CWT 2525B) BIG-TIP (BT+ 2530B) MYOBLATE (BTM 3530RB) JET-TIP® (JET 3530XB) JET-TIP® (JET 0710TB) JET-TIP® (JET 3025XB) JET-TIP® (JET 3015B) VARY-TIP (VCTU 10XXB) BIG-TIP (BT 1015OB) BIG-TIP (CWT 2510B) BIG-TIP (BT+ 2540B) BIG-TIP (BT+ 2520B) MYOBLATE (BTM 2030RB) MYOBLATE (BTM 2535RB) JET-TIP® (JET 0705TB) JET-TIP® (JET 2510XB) JET-TIP® (JET 0735TB) THYBLATE (RFT 07XXHL) BIG-TIP (BT 2515B) BIG-TIP (BT 1510B) BIG-TIP (CWT 1505B) BIG-TIP (BT+ 2535B) BIG-TIP (CWT 2005RB) BIG-TIP (CWT 1510RB) BIG-TIP (CWT 2530RB) MYOBLATE (BTM 2020QB) MYOBLATE (BTM 3010QB) JET-TIP® (JET 1015B) JET-TIP® (JET 1530QB) JET-TIP® (JET 3505QB) THYBLATE (RFTP 07XXLN) THYBLATE (RFT 07XXLN) BIG-TIP (BT 1040B) BIG-TIP (BTW 1515B) BIG-TIP (CWT 2005B) BIG-TIP (CWT 3505B) MYOBLATE (BTM 3505RB) MYOBLATE (BTM 3015RB) JET-TIP® (JET 0730TB) JET-TIP® (JET 2030QB) JET-TIP® (JET 2525XB) THYBLATE (RFT 07XXHLN) BIG-TIP (BT 1020OB) BIG-TIP (BT 1010OB) BIG-TIP (BTW 2020B) BIG-TIP (BT+ 1540B) BIG-TIP (BT+ 2510B) MYOBLATE (BTM 3540QB) MYOBLATE (BTM 2040RB) JET-TIP® (JET 1540QB) JET-TIP® (JET 2040XB) THYBLATE (RFT 07XXN) THYBLATE (RFTS 07XX) BIG-TIP (BT 0630PB) BIG-TIP (CWT 3525B) BIG-TIP (BT+ 1520B) BIG-TIP (BT+ 1515B) BIG-TIP (CWT 3535B) BIG-TIP (CWT 2505B) BIG-TIP (BT+ 1510B) MYOBLATE (BTM 3510RB) JET-TIP® (JET 1510QB) JET-TIP® (JET 1030B) THYBLATE (RFTP 10XXHL) THYBLATE (RFTS 07XXN) BIG-TIP (BT 2010B) BIG-TIP (BT 2015B) BIG-TIP (BTW 2005B) BIG-TIP (BTW 1535B) BIG-TIP (CWT 3515RB) MYOBLATE (BTM 3010RB) MYOBLATE (BTM 2040QB) JET-TIP® (JET 2015B) JET-TIP® (JET 1010B) JET-TIP® (JET 0725TB) VARY-TIP (VCTU 20XXB) BIG-TIP (BT 0615B) BIG-TIP (CWT 1530RB) BIG-TIP (CWT 2510RB) BIG-TIP (CWT 2520RB) BIG-TIP (CWT 3530B) MYOBLATE (BTM 3505QB) JET-TIP® (JET 3520QB) JET-TIP® (JET 2040QB) THYBLATE (RFT 10XXH) THYBLATE (RFT 07XX) BIG-TIP (BT 2535B) BIG-TIP (BT 1030B) BIG-TIP (BT+ 2020B) BIG-TIP (BTW 2040B) MYOBLATE (BTM 2510QB) MYOBLATE (BTM 3525RB) JET-TIP® (JET 2035QB) JET-TIP® (JET 2030B) JET-TIP® (JET 1525B) THYBLATE (RFTS 07XXLN) BIG-TIP (BT 1025OB) BIG-TIP (BT 1535B) BIG-TIP (BT+ 2525B) BIG-TIP (BTW 2025B) BIG-TIP (CWT 1505RB) MYOBLATE (BTM 3040QB) MYOBLATE (BTM 2010RB) JET-TIP® (JET 2515XB) JET-TIP® (JET 2505XB) JET-TIP® (JET 1510XB) THYBLATE (RFTPSP 07XXN) BIG-TIP (BT 0607PB) BIG-TIP (BT 0605PB) BIG-TIP (CWT 1540B) BIG-TIP (CWT 1530B) MYOBLATE (BTM 2515RB) MYOBLATE (BTM 2025QB) JET-TIP® (JET 3035QB) JET-TIP® (JET 3030B) JET-TIP® (JET 1005B) JET-TIP® (JET 2535XB) VARY-TIP (VCTU 15XXB) BIG-TIP (BT 0620B) BIG-TIP (BT 0625B) BIG-TIP (CWT 3540RB) BIG-TIP (CWT 1515B) BIG-TIP (CWT 2530B) MYOBLATE (BTM 2015QB) MYOBLATE (BTM 2505RB) JET-TIP® (JET 0720TB) JET-TIP® (JET 3010B) JET-TIP® (JET 2015XB) BIG-TIP (BT 2530B) BIG-TIP (BT 1505B) BIG-TIP (CWT 2540B) BIG-TIP (BTW 1540B) BIG-TIP (BTW 2010B) BIG-TIP (CWT 2035B) BIG-TIP (CWT 1540RB) MYOBLATE (BTM 2020RB) MYOBLATE (BTM 2520QB) JET-TIP® (JET 3510QB) JET-TIP® (JET 2510QB) THYBLATE (RFT 10XXN) BIG-TIP (BT 0635B) BIG-TIP (BT 1520B) BIG-TIP (CWT 2540RB) MYOBLATE (BTM 3020RB) MYOBLATE (BTM 3535QB) JET-TIP® (JET 0740TB) JET-TIP® (JET 2530XB) JET-TIP® (JET 2010QB) JET-TIP® (JET 3020QB) JET-TIP® (JET 1520XB) THYBLATE (RFTS 07XXL) Mygen V-1000 RF Generator THYBLATE (RFT 10XXN) THYBLATE (RFT 10XXHL) THYBLATE (RFTSP 07XXN) THYBLATE (RFTSP 10XXLN) THYBLATE (RFT 10XXLN) THYBLATE (RFTP 10XXLN) THYBLATE (RFT 07XX) THYBLATE (RFT 07XXLN) THYBLATE (RFT 07XXHN) THYBLATE (RFTP 07XXHN) THYBLATE (RFT 07XXN) THYBLATE (RFTP 10XXHL) THYBLATE (RFTP 07XXHL) THYBLATE (RFTP 07XXN) THYBLATE (RFT 07XXHL) THYBLATE (RFTP 10XXHLN) THYBLATE (RFT 07XXH) THYBLATE (RFTS 07XXLN) THYBLATE (RFTS 07XX) THYBLATE (RFT 10XX) THYBLATE (RFT 07XXL) THYBLATE (RFTP 07XXHLN) THYBLATE (RFT 10XXHN) THYBLATE (RFTP 10XXHN) THYBLATE (RFTS 07XXL) THYBLATE (RFTSP 07XXLN) THYBLATE (RFTS 07XXN) THYBLATE (RFTSP 10XXN) THYBLATE (RFT 10XXHLN) THYBLATE (RFTP 10XXN) THYBLATE (RFT 07XXHLN) THYBLATE (RFT 10XXL) THYBLATE (RFTP 07XXLN) VertiBlate(BRT 1825B) MYOBLATE-V(VCT 35XXB) V-TIP(VCTW 15XXB) OsteoBlate(BMDT 1310B) MYOBLATE-V(VCT 30XXB) V-TIP(VCTW 30XXB) OsteoBlate(BMDT 1920B) V-TIP(VCT 30XXB) THYBLATE-V(RFTVO 10XXV) VertiBlate(BRT 2115B) VertiBlate(BRT 1715B) V-TIP(VCT 15XXB) OsteoBlate(BMDT 1715B) OsteoBlate(BMDT 1815B) VertiBlate(BRT 2010B) OsteoBlate(BMDT 2010B) OsteoBlate(BMDT 1910B) V-TIP(VCT 25XXB) OsteoBlate(BMDT 1810B) OsteoBlate(BMDT 2015B) VertiBlate(BRT 1530B) OsteoBlate(BMDT 1720B) V-TIP(VCTW 35XXB) VertiBlate(BRT 1610B) THYBLATE-V(RFTVS 10XXV) THYBLATE-V2(RFTV2 10XXV) VertiBlate(BRT 1815B) VertiBlate(BRT 1910B) THYBLATE-V(RFTV 07XXV) OsteoBlate(BMDT 1420B) MYOBLATE-V(VCTM 30XXB) THYBLATE-V2(RFTVS2 10XXV) VertiBlate(BRT 1420B) VertiBlate(BRT 2110B) OsteoBlate(BMDT 1825B) THYBLATE-V(RFTVO 07XXV) OsteoBlate(BMDT 1915B) VertiBlate(BRT 2015B) VertiBlate(BRT 1830B) VertiBlate(BRT 1310B) MYOBLATE-V(VCT 25XXB) OsteoBlate(BMDT 2120B) VertiBlate(BRT 1315B) OsteoBlate(BMDT 2110B) THYBLATE-V(RFTVS 07XXV) V-TIP(VCT 12XXB) VertiBlate(BRT 1915B) VertiBlate(BRT 1820B) OsteoBlate(BMDT 1530B) V-TIP(VCTW 25XXB) VertiBlate(BRT 1920B) VertiBlate(BRT 1720B) VertiBlate(BRT 2120B) OsteoBlate(BMDT 2115B) V-TIP(VCT 35XXB) OsteoBlate(BMDT 1610B) VertiBlate(BRT 1810B) THYBLATE-V2(RFTV2 07XXV) MYOBLATE-V(VCTM 25XXB) OsteoBlate(BMDT 1315B) VertiBlate(BRT 1425B) V-TIP(VCT 20XXB) THYBLATE-V(RFTV 10XXV) OsteoBlate(BMDT 1830B) OsteoBlate(BMDT 1820B) V-TIP(VCTW 20XXB) VertiBlate(BRT 2020B) V-TIP(VCT 10XXB) V-TIP(VCTW 10XXB) OsteoBlate(BMDT 1425B) MYOBLATE-V(VCTM 35XXB) THYBLATE-V2(RFTVS2 07XXV) OsteoBlate(BMDT 2020B) Electrode Handpieces (BT, JET) BIG-TIP (BT 1525B) MYOBLATE (BTM 2010RB) BIG-TIP (BT 2010B) BIG-TIP (BT 2020B) BIG-TIP (BT 2030B) MYOBLATE (BTM 2020RB) BIG-TIP (BT 1010OB) BIG-TIP (BT 1015B) BIG-TIP (CWT 1525RB) BIG-TIP (CWT 1515RB) BIG-TIP (BTW 1515B) JET-TIP® (JET 1020B) BIG-TIP (CWT 1530RB) MYOBLATE (BTM 2025RB) JET-TIP® (JET 2005B) BIG-TIP (BT 2015B) BIG-TIP (BT 1515B) BIG-TIP (BTW 2010B) BIG-TIP (BT 1030B) BIG-TIP (BT 1020OB) BIG-TIP (BT 1005OB) BIG-TIP (BT 1020B) JET-TIP® (JET 2015B) BIG-TIP (BTW 1505B) JET-TIP® (JET 2020QB) JET-TIP® (JET 1525QB) BIG-TIP (CWT 2030RB) BIG-TIP (BTW 2025B) BIG-TIP (CWT 2020RB) BIG-TIP (BT 2025B) BIG-TIP (BTW 2020B) BIG-TIP (CWT 2005B) JET-TIP® (JET 1520B) MYOBLATE (BTM 2030RB) BIG-TIP (BTW 1520B) BIG-TIP (CWT 1520B) JET-TIP® (JET 1505QB) JET-TIP® (JET 1530B) BIG-TIP (CWT 1515B) JET-TIP® (JET 2005QB) JET-TIP® (JET 1030B) JET-TIP® (JET 1010B) BIG-TIP (BT 1005B) BIG-TIP (CWT 1510RB) JET-TIP® (JET 1530QB) BIG-TIP (BTW 1525B) BIG-TIP (CWT 2005RB) BIG-TIP (BTW 2030B) BIG-TIP (CWT 1510B) JET-TIP® (JET 2010B) BIG-TIP (BT 1520B) BIG-TIP (BTW 2005B) JET-TIP® (JET 1520QB) JET-TIP® (JET 1510QB) BIG-TIP (BT 1530B) BIG-TIP (CWT 2015B) JET-TIP® (JET 1515QB) JET-TIP® (JET 2030QB) BIG-TIP (BT 1010B) BIG-TIP (CWT 1505RB) BIG-TIP (BT 2005B) JET-TIP® (JET 1510B) JET-TIP® (JET 2020B) BIG-TIP (BT 1025B) BIG-TIP (BTW 2015B) BIG-TIP (CWT 2025B) BIG-TIP (BTW 1510B) BIG-TIP (CWT 2030B) JET-TIP® (JET 2010QB) BIG-TIP (BT 1015OB) JET-TIP® (JET 2015QB) MYOBLATE (BTM 2005RB) JET-TIP® (JET 2025B) JET-TIP® (JET 1015B) BIG-TIP (CWT 2025RB) BIG-TIP (BT 1030OB) BIG-TIP (CWT 1525B) BIG-TIP (CWT 1520RB) JET-TIP® (JET 2030B) BIG-TIP (CWT 2010RB) JET-TIP® (JET 1515B) JET-TIP® (JET 1525B) BIG-TIP (CWT 2010B) BIG-TIP (CWT 1505B) JET-TIP® (JET 1025B) MYOBLATE (BTM 2015RB) BIG-TIP (CWT 2020B) JET-TIP® (JET 2025QB) BIG-TIP (CWT 1530B) BIG-TIP (BTW 1530B) JET-TIP® (JET 1005B) JET-TIP® (JET 1505B) BIG-TIP (BT 1510B) BIG-TIP (CWT 2015RB) BIG-TIP (BT 1505B) BIG-TIP (BT 1025OB) Moving-Shot Guide Verti-N(VP 1580N) Verti-N(VP 136186) Verti-N(VP 1530N) Verti-N(VP 116166) Verti-N(VP 1480N) Verti-N(VP 131191) Verti-N(VP 126186) Verti-N(VP 131186) Verti-N(VP 1430N) Verti-N(VP 116176) Verti-N(VP 1180N) Verti-N(VP 1630N) Verti-N(VP 136191) Verti-N(VBI 148199) Verti-N(VP 1280N) Verti-N(VP 1330N) Verti-N(VP 116171) Verti-N(VP 1380N) Verti-N(VBI 128179) Verti-N(VP 141191)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-09-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-12-18
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2023-10-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-08-24
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2019-06-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-12-11

Official Correspondent

Kwang Sun Choi

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

RF MEDICAL CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0037-05	N/A	2	NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015136673. Last updated year: 2026. Please use registration number 3015136673 when referencing this establishment in official correspondence.