REPROCESSED TROCARS, MODEL B5LT AND CB5LT— 510(k) K100080

Clearance details

Applicant

Ascent Healthcare Solutions

Product code

Code NLM

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2010-01-12

Decision date

2010-03-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Phoenix, AZ, US

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• Z-2468-2015 — Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.Class II·Terminated·Stryker Sustainability Solutions·20150710

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100080.