Smith & Nephew Mis Instruments

K970949 is the FDA 510(k) clearance record for SMITH & NEPHEW MIS INSTRUMENTS, a class II device, cleared for Smith & Nephew Endoscopy, Inc. on 1997-04-23 under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ 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 18 510(k) clearances for Smith & Nephew Endoscopy, Inc., from 1996-07-16 to 2011-02-03. As of 2026-09-10, FDA records show no recalls naming K970949.