Onli Intermittent Catheter
K-Number: K163179 · 2017-01-26
ApplicantHollister Incorporated
Decision Date2017-01-26
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Onli Intermittent Catheter is a medical device manufactured by Hollister Incorporated. It received FDA 510(k) clearance on 2017-01-26 under approval number K163179. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Onli Intermittent Catheter?
Onli Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2017-01-26. It is manufactured by Hollister Incorporated. The 510(k) number is K163179.
When was Onli Intermittent Catheter approved by the FDA?
Onli Intermittent Catheter received FDA 510(k) clearance on 2017-01-26, under approval number K163179.
What company makes Onli Intermittent Catheter?
Onli Intermittent Catheter is manufactured by Hollister Incorporated.
What is the FDA product code for Onli Intermittent Catheter?
The FDA product code for Onli Intermittent Catheter is GBM.
Related Clinical Trials
Other Devices by Hollister Incorporated
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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.