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FDA 510(k)

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath

K-Number: K172217 · 2017-12-13

ApplicantCook Incorporated
Decision Date2017-12-13
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-12-13 under approval number K172217. 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 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath?

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Cook Incorporated. The 510(k) number is K172217.

When was Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath approved by the FDA?

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath received FDA 510(k) clearance on 2017-12-13, under approval number K172217.

What company makes Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath?

Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath is manufactured by Cook Incorporated.

What is the FDA product code for Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath?

The FDA product code for Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath is FED.

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED NCT07567456 Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients RECRUITING NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT07568990 Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery NOT_YET_RECRUITING NCT06547632 ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach TERMINATED NCT07557862 Multi-Site STARgraft (10401) Trial NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026)

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Related Devices (Code: FED)

K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. K160846AmplifEYEMedivators, Inc. K160861Proxis Ureteral Access SheathC.R. Bard, Inc. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. K181811ReTrace Ureteral Access SheathColoplast A/S

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.

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