Recall Z-0441-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-0441-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-03

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2014-11-03, terminated 2015-02-03. It names one FDA 510(k) clearance: K131861. Product: 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Terminated: 2015-02-03
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Data sourced from openFDA. This site is unofficial and independent of the FDA.