CO2 Laser Bronchoscope Coupler

K894962 is the FDA 510(k) clearance record for CO2 LASER BRONCHOSCOPE COUPLER, a class II device, cleared for Cuda Products Co. on 1989-09-28 under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 17 510(k) clearances for Cuda Products Co., from 1988-01-20 to 1998-12-16. As of 2026-09-10, FDA records show no recalls naming K894962.