FDA.reportPublic FDA data

Sutter

Primary DI
ESUM360100050
Brand
Sutter
Company
Sutter Medizintechnik GmbH
Model
360100-05
Catalog number
360100-05
Device description
RF-Generator CURIS® II mono- / bipolar modi
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESUM360100050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues 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 generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497641962560info@sutter-med.de

Regulatory Flags#

DUNS number
316625425
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESUMARS980010SutterAR-S9800-1AR-S9800-12026-08-27
ESUM3644100Sutter3644103644102026-05-22
ESUM700925SGS0Sutter700925SGS700925SGS2026-02-17
ESUM700951SGS0Sutter700951SGS700951SGS2026-02-17
ESUM700953SGS0Sutter700953SGS700953SGS2026-02-17
ESUM3601120Sutter3601123601122025-12-09
ESUMARS980500350SutterAR-S9805-0035AR-S9805-00352024-01-29
ESUM700957SGS0Sutter700957SGS700957SGS2025-08-15
ESUM700958SGS0Sutter700958SGS700958SGS2025-08-15
ESUM700951S0Sutter700951S700951S2025-07-21
ESUM700907SGS0Sutter700907SGS700907SGS2025-07-03
ESUM700911SGS0Sutter700911SGS700911SGS2025-07-03
ESUM700912SGS0Sutter700912SGS700912SGS2025-07-03
ESUM700917SGS0Sutter700917SGS700917SGS2025-07-03
ESUM700919SGS0Sutter700919SGS700919SGS2025-07-03
ESUM700920SGS0Sutter700920SGS700920SGS2025-07-03
ESUM700967SGS0Sutter700967SGS700967SGS2025-07-03
ESUM700969SGS0Sutter700969SGS700969SGS2025-07-03
ESUM700987SGS0Sutter700987SGS700987SGS2025-07-03
ESUM700990SGS0Sutter700990SGS700990SGS2025-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26