ReTrace Ureteral Access Sheath
K-Number: K181811 · 2018-09-07
ApplicantColoplast A/S
Decision Date2018-09-07
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ReTrace Ureteral Access Sheath is a medical device manufactured by Coloplast A/S. It received FDA 510(k) clearance on 2018-09-07 under approval number K181811. 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 ReTrace Ureteral Access Sheath?
ReTrace Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Coloplast A/S. The 510(k) number is K181811.
When was ReTrace Ureteral Access Sheath approved by the FDA?
ReTrace Ureteral Access Sheath received FDA 510(k) clearance on 2018-09-07, under approval number K181811.
What company makes ReTrace Ureteral Access Sheath?
ReTrace Ureteral Access Sheath is manufactured by Coloplast A/S.
What is the FDA product code for ReTrace Ureteral Access Sheath?
The FDA product code for ReTrace Ureteral Access Sheath is FED.
Related Clinical Trials
Other Devices by Coloplast A/S
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K160861Proxis Ureteral Access SheathC.R. Bard, Inc.
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K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated
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.