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FDA 510(k)

RocaJJ Soft Stents

K-Number: K173734 · 2018-03-12

ApplicantPromepla Sam
Decision Date2018-03-12
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RocaJJ Soft Stents is a medical device manufactured by Promepla Sam. It received FDA 510(k) clearance on 2018-03-12 under approval number K173734. 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 RocaJJ Soft Stents?

RocaJJ Soft Stents is a medical device that received FDA 510(k) clearance on 2018-03-12. It is manufactured by Promepla Sam. The 510(k) number is K173734.

When was RocaJJ Soft Stents approved by the FDA?

RocaJJ Soft Stents received FDA 510(k) clearance on 2018-03-12, under approval number K173734.

What company makes RocaJJ Soft Stents?

RocaJJ Soft Stents is manufactured by Promepla Sam.

What is the FDA product code for RocaJJ Soft Stents?

The FDA product code for RocaJJ Soft Stents is FAD.

Other Devices by Promepla Sam

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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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