Recall Z-2163-2015— American Medical Systems Innovation Center - Silicon Valley

Name: FDA recall Z-2163-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-28

Class II · Terminated

Class II FDA medical device recall by American Medical Systems Innovation Center - Silicon Valley, initiated 2015-05-28, terminated 2016-01-19. It names one FDA 510(k) clearance: K140679. Product: 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).. Reason: validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products.

Recalling firm: American Medical Systems Innovation Center - Silicon Valley
Classification: Class II
Status: Terminated
Initiated: 2015-05-28
Terminated: 2016-01-19
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140679 — SUREFLEX LITHOTRIPSY LASER FIBERSAmerican Medical Systems·cleared 2014-06-20

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

365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).

Reason for recall

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

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