Recall Z-0001-2016— US Endoscopy Group Inc

Name: FDA recall Z-0001-2016
Creator: U.S. Food and Drug Administration
Published: 2015-07-14

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2015-07-14, terminated 2016-10-27. It names one FDA 510(k) clearance: K140763. Product: Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.. Reason: The company has determined the sterility cannot be assured for the affected lot..

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-14
Terminated: 2016-10-27
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K140763 — MONOFILAMENT POLYPECTOMY SNAREUnited States Endoscopy·cleared 2014-04-24

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

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

Reason for recall

The company has determined the sterility cannot be assured for the affected lot.

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