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The BiSure™ Laparoscopic Bipolar Forceps is intended for use during laparoscopic bipolar coagulation.

The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic use. Coagulation is achieved under laparoscopic visualization by applying electrosurgical energy to the forceps. The device is intended for use with bipolar outputs of compatible electrosurgical generators.

The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.

This K983743 document is a 510(k) submission for the BiSure™ Laparoscopic Bipolar Forceps and does not contain information regarding studies for acceptance criteria, device performance metrics, or clinical trial data.

The document explicitly states:
"Performance testing has been performed to verify that the device functions as intended and that design specifications have been satisfied."

However, it does not provide any specific details about the acceptance criteria, the results of the performance testing, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Olympus Bipolar Forceps K955623), primarily based on technological characteristics and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria. The changes mentioned are to non-patient contacting portions of the device, implying that the core functional performance related to coagulation is considered equivalent to the predicate.

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