FDA.reportPublic FDA data

10THERMA

Primary DI
08809709380350
Brand
10THERMA
Company
TENTECH Inc.
Model
TMHP02
Device description
10THERMA Handpiece
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K232992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K23299200010THERMATentech, Inc.2023-12-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809709380350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809709380350088097093803508809709380350

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693713346
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0880970938047310THERMA / XTHERMATIP TMET0.25-300/ XMET0.25-3002026-02-27
0880970938048010THERMA / XTHERMATIP TMET0.25-600/ XMET0.25-6002026-02-27
0880970938049710THERMA / XTHERMATIP TMFT4.0-300/ XMFT4.0-3002026-02-27
0880970938050310THERMA / XTHERMATIP TMFT4.0-600/ XMFT4.0-6002026-02-27
0880970938051010THERMA / XTHERMATIP TMFT4.0-900/ XMFT4.0-9002026-02-27
0880970938052710THERMA / XTHERMATIP TMFT5.0-300/ XMFT5.0-3002026-02-27
0880970938053410THERMA / XTHERMATIP TMFT5.0-600/ XMFT5.0-6002026-02-27
0880970938054110THERMA / XTHERMATIP TMFT5.0-900/ XMFT5.0-9002026-02-27
0880970938055810THERMA / XTHERMATIP TMBT20.0-500/ XMBT20.0-5002026-02-27
0880970938056510THERMA / XTHERMATIP TMBT20.0-1000/ XMBT20.0-10002026-02-27
0880970938034310THERMATMSY022024-06-28
0880970938041110PL10PL-Body2024-06-28
0880970938043510PL10PL-H/P2024-06-28
08809709380459XTHERMAXTHERMA-Body2024-06-25
08809709380466XTHERMAXTHERMA-H/P2024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426385MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426422MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426545MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426552MillenniumAvalign Technologies, Inc.GEI2026-08-18
00198506093982ELMED INCORPORATEDELMED INCORPORATEDGEI2026-08-18
00841019123898KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-18
00840113234356BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237705BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237712BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07