Dornier MAGELLAN Ureteral Access Sheath
K-Number: K201815 · 2020-11-20
ApplicantDornier Medtech America, Inc.
Decision Date2020-11-20
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Dornier MAGELLAN Ureteral Access Sheath is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2020-11-20 under approval number K201815. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dornier MAGELLAN Ureteral Access Sheath?
Dornier MAGELLAN Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K201815.
When was Dornier MAGELLAN Ureteral Access Sheath approved by the FDA?
Dornier MAGELLAN Ureteral Access Sheath received FDA 510(k) clearance on 2020-11-20, under approval number K201815.
What company makes Dornier MAGELLAN Ureteral Access Sheath?
Dornier MAGELLAN Ureteral Access Sheath is manufactured by Dornier Medtech America, Inc..
What is the FDA product code for Dornier MAGELLAN Ureteral Access Sheath?
The FDA product code for Dornier MAGELLAN Ureteral Access Sheath is FED.
Related Clinical Trials
Other Devices by Dornier Medtech America, Inc.
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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.