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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-08-28 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K170010.

When did Salle Intraoperative Pyeloplasty Stent Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Salle Intraoperative Pyeloplasty Stent Set?

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 Salle Intraoperative Pyeloplasty Stent Set?

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

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Related Devices (Code: FAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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