Intelijet Tm Fluid Management System

K912453 is the FDA 510(k) clearance record for INTELIJET TM FLUID MANAGEMENT SYSTEM, a class II device, cleared for Smith & Nephew Dyonics, Inc. on 1991-08-26 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 22 510(k) clearances for Smith & Nephew Dyonics, Inc., from 1990-04-18 to 1996-02-08. As of 2026-09-10, FDA records show no recalls naming K912453.