BIG-TIP (BT 1535B)

Registration Details

Registration Name: RF MEDICAL CO., LTD
Registration Number: 3015136673
FEI Number: 3015136673
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu
City: Seoul
Country: KR

Regulatory Submissions

510(k) Number: K221277

Owner / Operator

Firm Name: RF MEDICAL CO., LTD
Operator Number: 10059293
Address: #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu
City: Seoul
State: KR-11
Postal Code: 08513
Country: KR
Correspondent: Kwang Sun Choi

US Agent

Business Name: Mtech Group LLC
Contact Name: Dave Kim
Address: 7505 Fannin St. Suite 610
City: Houston
State: TX
ZIP: 77054
Country: US
Email: [email protected]
Phone: 713 4672607

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrosurgical, Cutting & Coagulation & Accessories	GEI	Class 2	General, Plastic Surgery	No	2022-09-06

Proprietary Names

BIG-TIP (BT 1535B) BIG-TIP (CWT 2040B) BIG-TIP (BT+ 2020B) BIG-TIP (CWT 3535RB) BIG-TIP (CWT 2520B) MYOBLATE (BTM 3525RB) JET-TIP® (JET 2030B) JET-TIP® (JET 3030XB) BIG-TIP (BT 2015B) BIG-TIP (CWT 2510B) BIG-TIP (BTW 2025B) BIG-TIP (BT+ 2520B) MYOBLATE (BTM 2010RB) JET-TIP® (JET 2505XB) JET-TIP® (JET 2510XB) JET-TIP® (JET 1535B) BIG-TIP (BT 1040OB) BIG-TIP (CWT 2010B) BIG-TIP (BTW 2030B) BIG-TIP (BT+ 1535B) MYOBLATE (BTM 2035RB) JET-TIP® (JET 2010XB) JET-TIP® (JET 1525XB) JET-TIP® (JET 2025QB) JET-TIP® (JET 1505XB) JET-TIP® (JET 1520QB) BIG-TIP (BT 1025B) BIG-TIP (BT 1025OB) BIG-TIP (CWT 3505RB) BIG-TIP (BT+ 2040B) MYOBLATE (BTM 3025RB) MYOBLATE (BTM 2510QB) JET-TIP® (JET 3520XB) JET-TIP® (JET 2515B) JET-TIP® (JET 2035XB) JET-TIP® (JET 2035QB) JET-TIP® (JET 2030XB) THYBLATE (RFTS 07XXLN) THYBLATE (RFTPS 07XXLN) THYBLATE (RFT 10XXLN) BIG-TIP (BT 2040B) BIG-TIP (BT 0610PB) BIG-TIP (BT+ 1520B) BIG-TIP (CWT 3535B) BIG-TIP (CWT 2505B) BIG-TIP (BT+ 1510B) MYOBLATE (BTM 3510RB) MYOBLATE (BTM 2025RB) JET-TIP® (JET 2025B) JET-TIP® (JET 1030B) JET-TIP® (JET 3035B) BIG-TIP (BT 1015OB) BIG-TIP (BT+ 1530B) BIG-TIP (BTW 2040B) MYOBLATE (BTM 2010QB) MYOBLATE (BTM 2530QB) JET-TIP® (JET 3030QB) JET-TIP® (JET 2520QB) JET-TIP® (JET 3020B) JET-TIP® (JET 3010QB) THYBLATE (RFT 10XXHN) BIG-TIP (BT 1005B) BIG-TIP (BT 1020B) BIG-TIP (CWT 1530RB) BIG-TIP (CWT 2520RB) BIG-TIP (CWT 3515B) MYOBLATE (BTM 3505QB) MYOBLATE (BTM 3515QB) JET-TIP® (JET 3520QB) JET-TIP® (JET 2525QB) JET-TIP® (JET 3525XB) THYBLATE (RFT 07XXHN) BIG-TIP (BT 0620B) BIG-TIP (BT 2540B) BIG-TIP (CWT 2535B) BIG-TIP (CWT 2030B) BIG-TIP (BTW 2035B) BIG-TIP (CWT 2025B) MYOBLATE (BTM 3030QB) MYOBLATE (BTM 3530QB) JET-TIP® (JET 1535XB) JET-TIP® (JET 2515QB) JET-TIP® (JET 3015QB) THYBLATE (RFT 07XXN) BIG-TIP (BT 2025B) BIG-TIP (CWT 1535B) BIG-TIP (CWT 2020RB) BIG-TIP (BT+ 2530B) MYOBLATE (BTM 3540RB) MYOBLATE (BTM 2005QB) JET-TIP® (JET 2015QB) JET-TIP® (JET 3505XB) JET-TIP® (JET 1040B) JET-TIP® (JET 0715TB) BIG-TIP (BT 2030B) BIG-TIP (BT 0615PB) BIG-TIP (CWT 1515B) BIG-TIP (CWT 2505RB) MYOBLATE (BTM 2505RB) MYOBLATE (BTM 2030QB) JET-TIP® (JET 0720TB) JET-TIP® (JET 1020B) JET-TIP® (JET 3515QB) THYBLATE (RFTP 07XXHN) BIG-TIP (BT 1030OB) BIG-TIP (CWT 1515RB) BIG-TIP (BT+ 2010B) BIG-TIP (CWT 2530B) BIG-TIP (CWT 2010RB) MYOBLATE (BTM 3005RB) JET-TIP® (JET 3010XB) JET-TIP® (JET 2520XB) JET-TIP® (JET 2015XB) JET-TIP® (JET 1525B) BIG-TIP (BT 2505B) BIG-TIP (BT 0640B) BIG-TIP (CWT 2020B) BIG-TIP (CWT 2515B) MYOBLATE (BTM 2540RB) MYOBLATE (BTM 2015RB) JET-TIP® (JET 2505QB) JET-TIP® (JET 1515XB) JET-TIP® (JET 1535QB) THYBLATE (RFTP 10XXLN) BIG-TIP (BT 1505B) BIG-TIP (BT 0640PB) BIG-TIP (BTW 1515B) BIG-TIP (BTW 1535B) BIG-TIP (CWT 3505B) MYOBLATE (BTM 2040QB) MYOBLATE (BTM 3015RB) JET-TIP® (JET 0725TB) JET-TIP® (JET 2030QB) BIG-TIP (BT 1540B) BIG-TIP (CWT 2005B) BIG-TIP (CWT 1540B) BIG-TIP (CWT 3515RB) MYOBLATE (BTM 3505RB) MYOBLATE (BTM 2515RB) JET-TIP® (JET 2015B) JET-TIP® (JET 3035QB) JET-TIP® (JET 2525XB) VARY-TIP (VCTU 15XXB) THYBLATE (RFTP 10XXHLN) BIG-TIP (BT 2520B) BIG-TIP (BT 2515B) BIG-TIP (BT 1510B) BIG-TIP (CWT 1520B) BIG-TIP (BTW 1505B) BIG-TIP (BTW 1520B) BIG-TIP (CWT 3520RB) MYOBLATE (BTM 2505QB) MYOBLATE (BTM 3515RB) MYOBLATE (BTM 3535RB) JET-TIP® (JET 3535QB) JET-TIP® (JET 2005XB) THYBLATE (RFT 10XXH) BIG-TIP (BT 1010B) BIG-TIP (BT 2020B) BIG-TIP (BT+ 2535B) BIG-TIP (CWT 1525B) BIG-TIP (CWT 2005RB) BIG-TIP (CWT 1510RB) BIG-TIP (CWT 2530RB) MYOBLATE (BTM 3005QB) MYOBLATE (BTM 3010QB) JET-TIP® (JET 1025B) JET-TIP® (JET 3505QB) THYBLATE (RFT 10XXHL) BIG-TIP (BT 1005OB) BIG-TIP (BT+ 1505B) BIG-TIP (CWT 2510RB) MYOBLATE (BTM 3035RB) JET-TIP® (JET 2025XB) JET-TIP® (JET 2540B) JET-TIP® (JET 2035B) JET-TIP® (JET 2040QB) THYBLATE (RFT 07XX) BIG-TIP (BT 0620PB) BIG-TIP (CWT 2035RB) BIG-TIP (BT+ 2510B) MYOBLATE (BTM 3510QB) JET-TIP® (JET 3525QB) JET-TIP® (JET 3535XB) JET-TIP® (JET 2540QB) JET-TIP® (JET 3530XB) JET-TIP® (JET 1530XB) JET-TIP® (JET 3025XB) VARY-TIP (VCTU 10XXB) BIG-TIP (BT 1015B) BIG-TIP (BTW 1530B) BIG-TIP (CWT 3540RB) BIG-TIP (CWT 3530B) BIG-TIP (CWT 2015RB) MYOBLATE (BTM 2015QB) MYOBLATE (BTM 2540QB) JET-TIP® (JET 2540XB) JET-TIP® (JET 2505B) JET-TIP® (JET 2520B) JET-TIP® (JET 3010B) VARY-TIP (VCTU 12XXB) BIG-TIP (BT 2005B) BIG-TIP (BTW 2020B) BIG-TIP (CWT 2525RB) BIG-TIP (BT 2525B) BIG-TIP (BT 2530B) BIG-TIP (BT+ 1540B) BIG-TIP (CWT 2015B) BIG-TIP (BT+ 2025B) MYOBLATE (BTM 2040RB) JET-TIP® (JET 2040XB) BIG-TIP (CWT 1525RB) JET-TIP® (JET 3005XB) JET-TIP® (JET 3015B) BIG-TIP (BTW 2005B) MYOBLATE (BTM 2525RB) MYOBLATE (BTM 3010RB) JET-TIP® (JET 3040QB) JET-TIP® (JET 1505QB) JET-TIP® (JET 1010B) JET-TIP® (JET 3020XB) JET-TIP® (JET 3015XB) VARY-TIP (VCTU 20XXB) THYBLATE (RFT 07XXHLN) BIG-TIP (BT 0607PB) BIG-TIP (BT 1040B) BIG-TIP (BT+ 2540B) BIG-TIP (CWT 1505RB) MYOBLATE (BTM 2030RB) MYOBLATE (BTM 3020RB) MYOBLATE (BTM 2535RB) JET-TIP® (JET 0740TB) JET-TIP® (JET 2530XB) JET-TIP® (JET 0735TB) THYBLATE (RFTS 07XXL) THYBLATE (RFTP 10XXHL) BIG-TIP (BT 0630PB) BIG-TIP (BT 1515B) BIG-TIP (CWT 2540B) BIG-TIP (BTW 2015B) BIG-TIP (BTW 2010B) BIG-TIP (CWT 2035B) BIG-TIP (CWT 1540RB) MYOBLATE (BTM 2520QB) MYOBLATE (BTM 3040RB) JET-TIP® (JET 2510QB) JET-TIP® (JET 1530B) BIG-TIP (BT 1035B) BIG-TIP (BT 2510B) BIG-TIP (CWT 1505B) BIG-TIP (CWT 3520B) MYOBLATE (BTM 3015QB) MYOBLATE (BTM 2020QB) JET-TIP® (JET 1510B) JET-TIP® (JET 1540B) JET-TIP® (JET 1530QB) JET-TIP® (JET 2525B) THYBLATE (RFT 07XXLN) BIG-TIP (BT 0635B) BIG-TIP (BT 1520B) Mygen M-3004 RF Generator BIG-TIP (CWT 2515RB) BIG-TIP (BTW 1540B) MYOBLATE (BTM 2005RB) MYOBLATE (BTM 2020RB) JET-TIP® (JET 3510XB) JET-TIP® (JET 2040B) JET-TIP® (JET 2535QB) JET-TIP® (JET 3025B) THYBLATE (RFT 10XXN) THYBLATE (RFTP 07XXN) BIG-TIP (BT 0615B) BIG-TIP (BT 1035OB) BIG-TIP (BT+ 2005B) BIG-TIP (CWT 2040RB) BIG-TIP (CWT 2025RB) MYOBLATE (BTM 3025QB) MYOBLATE (BTM 2515QB) JET-TIP® (JET 2020B) JET-TIP® (JET 1540XB) JET-TIP® (JET 3005B) THYBLATE (RFTP 10XXHN) BIG-TIP (BT 0625PB) BIG-TIP (BT 2010B) BIG-TIP (CWT 3530RB) BIG-TIP (BT+ 2525B) BIG-TIP (CWT 3525RB) MYOBLATE (BTM 2520RB) MYOBLATE (BTM 3040QB) JET-TIP® (JET 1525QB) JET-TIP® (JET 1035B) JET-TIP® (JET 2515XB) JET-TIP® (JET 3530QB) THYBLATE (RFTPSP 07XXN) THYBLATE (RFT 07XXHL) BIG-TIP (BT 0605PB) BIG-TIP (CWT 3525B) BIG-TIP (CWT 2540RB) BIG-TIP (BT+ 1515B) MYOBLATE (BTM 3535QB) JET-TIP® (JET 0705TB) JET-TIP® (JET 2010QB) JET-TIP® (JET 3020QB) JET-TIP® (JET 1520XB) THYBLATE (RFTS 07XXN) BIG-TIP (BT 0605B) BIG-TIP (CWT 3510RB) BIG-TIP (CWT 1530B) BIG-TIP (BT 0630B) MYOBLATE (BTM 2025QB) JET-TIP® (JET 0730TB) JET-TIP® (JET 3030B) JET-TIP® (JET 2530B) JET-TIP® (JET 1005B) BIG-TIP (CWT 1535RB) JET-TIP® (JET 2535XB) THYBLATE (RFT 10XXL) BIG-TIP (CWT 3540B) MYOBLATE (BTM 3520QB) MYOBLATE (BTM 2535QB) JET-TIP® (JET 3510QB) JET-TIP® (JET 2010B) JET-TIP® (JET 3540XB) JET-TIP® (JET 2005QB) THYBLATE (RFT 07XXH) THYBLATE (RFTP 07XXLN) BIG-TIP (BT 2535B) BIG-TIP (BT 1030B) BIG-TIP (CWT 2525B) BIG-TIP (BTW 1510B) BIG-TIP (CWT 2535RB) MYOBLATE (BTM 3530RB) MYOBLATE (BTM 3030RB) JET-TIP® (JET 0710TB) JET-TIP® (JET 2510B) THYBLATE (RFTP 10XXN) BIG-TIP (BT 1530B) BIG-TIP (BT+ 2505B) BIG-TIP (CWT 3510B) BIG-TIP (BT+ 2015B) MYOBLATE (BTM 2510RB) MYOBLATE (BTM 3020QB) JET-TIP® (JET 3040XB) JET-TIP® (JET 3025QB) JET-TIP® (JET 3515XB) JET-TIP® (JET 1510XB) BIG-TIP (BT 0625B) BIG-TIP (BT 0610B) BIG-TIP (BT+ 2515B) MYOBLATE (BTM 2530RB) MYOBLATE (BTM 3540QB) JET-TIP® (JET 1515QB) JET-TIP® (JET 2020XB) JET-TIP® (JET 1540QB) JET-TIP® (JET 2535B) THYBLATE (RFTS 07XX) THYBLATE (RFT 10XXHLN) BIG-TIP (BT 1020OB) BIG-TIP (BT 1010OB) BIG-TIP (BT+ 2035B) BIG-TIP (BT+ 2030B) BIG-TIP (BT+ 1525B) BIG-TIP (CWT 1510B) MYOBLATE (BTM 2525QB) MYOBLATE (BTM 3035QB) JET-TIP® (JET 3540QB) JET-TIP® (JET 1515B) JET-TIP® (JET 2005B) THYBLATE (RFTP 07XXHL) BIG-TIP (BT 0635PB) BIG-TIP (BT 1525B) BIG-TIP (BTW 1525B) BIG-TIP (CWT 1520RB) MYOBLATE (BTM 3525QB) MYOBLATE (BTM 2035QB) JET-TIP® (JET 1510QB) JET-TIP® (JET 3040B) JET-TIP® (JET 2020QB) JET-TIP® (JET 1505B) THYBLATE (RFTP 07XXHLN) THYBLATE (RFT 10XX) BIG-TIP (BT 2035B) BIG-TIP (CWT 2030RB) MYOBLATE (BTM 3520RB) JET-TIP® (JET 1015B) JET-TIP® (JET 3035XB) JET-TIP® (JET 2530QB) JET-TIP® (JET 1520B) JET-TIP® (JET 3005QB) THYBLATE (RFT 07XXL)

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198