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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-06-17 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K182695.

When did Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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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