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510(k) Data Aggregation
K Number
K992760Device Name
SELECT-SUTTER MICRO BIPOLAR FORCEPS
Manufacturer
Date Cleared
1999-10-25
(69 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SELECT MEDIZINTECHNIK HERMANN SUTTER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Select-Sutter Micro-Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. This product is used with bipolar output of standard electrosurgical generators. The types of surgery intended are:
General sugery
Laparoscopic procedures
Endoscopic procedures
Laryngeal coagulation
Orthopedic coagulation
Thorascopic coagulation
Neurosurgical coagulation
Gynecological coagulation, (except for use in female sterilization)
Ear, Nose and Throat coagulation
Device Description
The Micro-Bipolar Forceps Device is a laparoscopic and endoscopic device used for the grasping and general coagulation/cutting and pinpoint coagulation of tissue using electrosurgical energy under visualization. The device is used with bipolar outputs of electrosurgical generators and has reusuable probes for grasping/coagulation and pinpoint coagulation.
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