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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 the device name listed in this FDA 510(k) record. The listed applicant is Partnership Medical Limited. It received FDA 510(k) clearance on 2019-07-11 under 510(k) 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. The listed applicant is Partnership Medical Limited. The 510(k) number is K181418.

When did ScopeFlow Pure(TM) receive FDA 510(k) clearance?

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

Who is the listed applicant for ScopeFlow Pure(TM)?

The FDA 510(k) record lists Partnership Medical Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Partnership Medical Limited as applicant

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.

K181457EndoStream(TM)

Related Devices (Code: OCX)

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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