FDA.reportPublic FDA data

Sutter

Primary DI
ESUM700987SGS0
Brand
Sutter
Company
Sutter Medizintechnik GmbH
Model
700987SGS
Catalog number
700987SGS
Device description
Calvian endo-pen®, straight, US 15°, WL18cm, forceps style tip 1.2mm, non-stick
Published
2025-07-03
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
ESUM700987SGS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
316625425
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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
ESUM700990SGS0Sutter700990SGS700990SGS2025-07-03
ESUM700998SGS0Sutter700998SGS700998SGS2025-07-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01