FDA.reportPublic FDA data

Super Pencil

Primary DI
00860016247017
Brand
Super Pencil
Company
RF KINETICS LLC
Model
HB1-EP-100-3-AE-EBDNI
Device description
The Super Pencil is a sterile, single-use, hand-controlled electrosurgical pencil intended for connection to a compatible electrosurgical generator for cutting and coagulation of tissue. This model includes a standard-length 70 mm (2.75-inch), insulated electrode packaged together with the pencil in a sealed sterile pouch. A separate sterile pouch containing an electrosurgical pencil holster is also included. Both sterile pouches are supplied together in one box. The pencil features two-button controls for cutting and coagulation.
Published
2026-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K231405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231405000Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick ElectrodeJiangsu Rong FU Kang Medical Instruments Co., Ltd.2024-01-18GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016247055PackageGS120In Commercial Distribution
00860016247017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016247055008600162470558600162470550860016247055
00860016247017008600162470178600162470170860016247017

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Regulatory Flags#

DUNS number
130200054
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860016247000Super PencilHB1-EP-100-3-AE-EBDN2026-10-17
00860016247024Super PencilHB1-EP-100-3-AE-EBDNI42026-10-17
00860016247031Super PencilHB1-EP-100-3-AE-EBDNI62026-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
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00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
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B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
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00190776434083MillenniumAvalign Technologies, Inc.GEI2026-10-09