FDA.reportPublic FDA data

Sutter

Primary DI
ESUMARS980010
Brand
Sutter
Company
Sutter Medizintechnik GmbH
Model
AR-S9800-1
Catalog number
AR-S9800-1
Device description
Synergy Electrosurgery RF Generator Distributed by Arthrex
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
ESUMARS980010PrimaryHIBCC0

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.

Contacts#

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

Regulatory Flags#

DUNS number
316625425
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
ESUM3644100Sutter3644103644102026-05-22
ESUM360100050Sutter360100-05360100-052026-02-18
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
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
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
00841019123928KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-22
00190776427153MillenniumAvalign Technologies, Inc.GEI2026-08-21
B382SD83042110011NS0Surgical DirectSurgical Direct, Inc.GEI2026-08-21
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