(67 days)
The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.
The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.
This document is a 510(k) summary for a medical device (KSEA Bipolar Coagulating Forceps), not a study report describing acceptance criteria and device performance evaluation based on clinical data.
Therefore, I cannot provide the requested information, which typically pertains to the evaluation of AI/ML-driven devices or diagnostic tools. The content provided describes a surgical instrument and focuses on its design, intended use, and substantial equivalence to predicate devices, rather than a performance study with acceptance criteria.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.