(13 days)
The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures.
The KSEA Huzly high-frequency cutting loops are manually operated, reusable surgical devices consisting of a bronchoscope tube with a cutting loop and connection for a highfrequency cord. The Huzly high-frequency cutting loops are available in both adult and pediatric sizes, which are long enough to gain access to the surgical area. The body contact materials are surgical grade stainless steel and tungsten.
This document is a 510(k) summary for a medical device (KSEA Huzly high-frequency cutting loops) and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, device description, and intended use, rather than presenting a performance study with specific acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.