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FDA 510(k)

Obturys

K-Number: K170207 · 2017-07-31

ApplicantItena Clinical
Decision Date2017-07-31
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Obturys is a medical device manufactured by Itena Clinical. It received FDA 510(k) clearance on 2017-07-31 under approval number K170207. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Obturys?

Obturys is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Itena Clinical. The 510(k) number is K170207.

When was Obturys approved by the FDA?

Obturys received FDA 510(k) clearance on 2017-07-31, under approval number K170207.

What company makes Obturys?

Obturys is manufactured by Itena Clinical.

What is the FDA product code for Obturys?

The FDA product code for Obturys is KIF.

Other Devices by Itena Clinical

K162960TotalC-Ram

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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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