Laparoscopic Handles with peek Insulation

Laparoscopic Handles with peek Insulation is an FDA 510(k)-cleared medical device (K150127) manufactured by Stryker Endoscopy. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 2015. Regulation: 8.