Trans1 Trans-Sacral Spinal Access and Preparation Kit

K032891 is the FDA 510(k) clearance record for TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT, a class II device, cleared for Trans1, Inc. on 2004-01-15 under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 5 510(k) clearances for Trans1, Inc., from 2004-01-15 to 2019-11-20. As of 2026-09-10, FDA records show no recalls naming K032891.