Lehman Manometry Catheter
K-Number: K160170 · 2016-06-20
ApplicantWilson-Cook Medical, Inc.
Decision Date2016-06-20
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Lehman Manometry Catheter is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2016-06-20 under approval number K160170. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lehman Manometry Catheter?
Lehman Manometry Catheter is a medical device that received FDA 510(k) clearance on 2016-06-20. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K160170.
When was Lehman Manometry Catheter approved by the FDA?
Lehman Manometry Catheter received FDA 510(k) clearance on 2016-06-20, under approval number K160170.
What company makes Lehman Manometry Catheter?
Lehman Manometry Catheter is manufactured by Wilson-Cook Medical, Inc..
What is the FDA product code for Lehman Manometry Catheter?
The FDA product code for Lehman Manometry Catheter is FFX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.