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FDA 510(k)

ScopeFlow Pure(TM)

K-Number: K181418 · 2019-07-11

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

Device Summary

ScopeFlow Pure(TM) is a medical device manufactured by Partnership Medical Limited. It received FDA 510(k) clearance on 2019-07-11 under approval number K181418. 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 ScopeFlow Pure(TM)?

ScopeFlow Pure(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 K181418.

When was ScopeFlow Pure(TM) approved by the FDA?

ScopeFlow Pure(TM) received FDA 510(k) clearance on 2019-07-11, under approval number K181418.

What company makes ScopeFlow Pure(TM)?

ScopeFlow Pure(TM) is manufactured by Partnership Medical Limited.

What is the FDA product code for ScopeFlow Pure(TM)?

The FDA product code for ScopeFlow Pure(TM) is OCX.

Other Devices by Partnership Medical Limited

K181457EndoStream(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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