PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

K231970 is the FDA 510(k) clearance record for PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock, a class II device, cleared for Pentax of America, Inc. on 2024-01-12 under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "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. If the...". FDA records list 72 510(k) clearances for Pentax of America, Inc., from 2004-10-19 to 2025-12-16. As of 2026-09-10, FDA records show no recalls naming K231970.