FDA.reportPublic FDA data

BIG-TIP™

Primary DI
08809295141137
Brand
BIG-TIP™
Company
RF Medical Co.,Ltd.
Model
BT 1525B
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K193355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193355000Electrodes Handpieces for Mygen V-1000 RF SystemRF Medical Co., Ltd.2020-08-03GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809295141137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809295141137088092951411378809295141137

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolarA semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690514869
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800142906435BIG-TIP™BT 1030OB2025-09-05
08800142906442BIG-TIP™BT 1035OB2025-09-05
08800142906459BIG-TIP™BT 1040OB2025-09-05
08800142906534BIG-TIP™BT+1505B2025-09-05
08800142906541BIG-TIP™BT+ 2005B2025-09-05
08800142906558BIG-TIP™BT+ 2010B2025-09-05
08800142906565BIG-TIP™BT+ 2015B2025-09-05
08800142906572BIG-TIP™BT+ 2505B2025-09-05
08800142906886BIG-TIP™CWT 3505B2025-09-05
08800142906893BIG-TIP™CWT 3535B2025-09-05
08800142906909BIG-TIP™CWT 3540B2025-09-05
08800142907005BIG-TIP™CWT 3505RB2025-09-05
08800142907012BIG-TIP™CWT 3535RB2025-09-05
08800142907029BIG-TIP™CWT 3540RB2025-09-05
08800142909672BIG-TIP™JET 1020B2025-09-05
08800142909689JET-TIP®JET 1025B2025-09-05
08800142909719JET-TIP®JET 1505B2025-09-05
08800142909726JET-TIP®JET 2005B2025-09-05
08800142909733JET-TIP®JET 1505QB2025-09-05
08800142909740JET-TIP®JET 1510QB2025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
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