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
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10