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FDA 510(k)

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

K-Number: K182695 · 2019-06-17

ApplicantCook Incorporated
Decision Date2019-06-17
Product CodeEYB
Advisory CommitteeGU
DecisionUnknown

Device Summary

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-06-17 under approval number K182695. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2019-06-17. It is manufactured by Cook Incorporated. The 510(k) number is K182695.

When was Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter approved by the FDA?

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter received FDA 510(k) clearance on 2019-06-17, under approval number K182695.

What company makes Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

The FDA product code for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is EYB.

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Related Devices (Code: EYB)

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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.

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