FDA.reportPublic FDA data

RF Micro Needle Tip

Primary DI
08800016273076
Brand
RF Micro Needle Tip
Company
Hironic Co., ltd.
Model
RMT-I49
Published
2026-04-15
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

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
K233123000
K251334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233123000SILKROHironic Co., Ltd.2024-06-24GEI
K251334000NEW DOUBLO 2.0Hironic Co., Ltd.2025-09-29GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016273076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016273076088000162730768800016273076

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Contacts#

Phone, Email table
PhoneEmail
+8215994299ocs@hironic.com

Regulatory Flags#

DUNS number
557803630
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016213140NEW DOUBLO 2.0NEW DOUBLO 2.02026-04-15
08800016273014A-FIT RF Needle TipA-FIT RN 1.22026-04-15
08800016273021A-FIT RF Needle TipA-FIT RN 1.52026-04-15
08800016273038A-FIT RF Needle TipA-FIT RN 1.82026-04-15
08800016273045RF Micro Needle TipRMT-N252026-04-15
08800016273052RF Micro Needle TipRMT-I252026-04-15
08800016273069RF Micro Needle TipRMT-N492026-04-15
08800016273083RM HandpieceRM Handpiece2026-04-15
08800016273090RM(B) HandpieceRM(B) Handpiece2026-04-15
08800016273106PS HandpiecePS Handpiece2026-04-15
08800016273120RN HandpieceRN Handpiece2026-04-15
08800016273137RC HandpieceRC Handpiece2026-04-15
08800016273144RV HandpieceRV Handpiece2026-04-15
08800016273151GP CableGP Cable2026-04-15
08800016273182RF Venus StickRF Venus Stick2026-04-15
08800016273250PS TipPS Tip2026-04-15
08800016213034PLASONICPLASONIC2026-03-18
08800016213027SILKROSILKRO2024-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17