Apex Universal Irrigation System & Two-Connection Tubing Set

K961590 is the FDA 510(k) clearance record for APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET, a class II device, cleared for Linvatec Corp. on 1996-10-08 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 93 510(k) clearances for Linvatec Corp., from 1992-08-06 to 2009-12-23. As of 2026-09-10, FDA records show one recall naming K961590.