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FDA 510(k)

EndoStream(TM)

K-Number: K181457 · 2019-07-11

ApplicantPartnership Medical Limited
Decision Date2019-07-11
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoStream(TM) is a medical device manufactured by Partnership Medical Limited. It received FDA 510(k) clearance on 2019-07-11 under approval number K181457. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoStream(TM)?

EndoStream(TM) is a medical device that received FDA 510(k) clearance on 2019-07-11. It is manufactured by Partnership Medical Limited. The 510(k) number is K181457.

When was EndoStream(TM) approved by the FDA?

EndoStream(TM) received FDA 510(k) clearance on 2019-07-11, under approval number K181457.

What company makes EndoStream(TM)?

EndoStream(TM) is manufactured by Partnership Medical Limited.

What is the FDA product code for EndoStream(TM)?

The FDA product code for EndoStream(TM) is OCX.

Other Devices by Partnership Medical Limited

K181418ScopeFlow Pure(TM)

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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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