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FDA 510(k)

Salle Intraoperative Pyeloplasty Stent Set

K-Number: K170010 · 2017-08-28

ApplicantCook Incorporated
Decision Date2017-08-28
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Salle Intraoperative Pyeloplasty Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-08-28 under approval number K170010. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Salle Intraoperative Pyeloplasty Stent Set?

Salle Intraoperative Pyeloplasty Stent Set is a medical device that received FDA 510(k) clearance on 2017-08-28. It is manufactured by Cook Incorporated. The 510(k) number is K170010.

When was Salle Intraoperative Pyeloplasty Stent Set approved by the FDA?

Salle Intraoperative Pyeloplasty Stent Set received FDA 510(k) clearance on 2017-08-28, under approval number K170010.

What company makes Salle Intraoperative Pyeloplasty Stent Set?

Salle Intraoperative Pyeloplasty Stent Set is manufactured by Cook Incorporated.

What is the FDA product code for Salle Intraoperative Pyeloplasty Stent Set?

The FDA product code for Salle Intraoperative Pyeloplasty Stent Set is FAD.

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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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