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FDA 510(k)

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F

K-Number: K221020 · 2023-01-13

ApplicantPotrero Medical, Inc.
Decision Date2023-01-13
Product CodeEZL
Advisory CommitteeGU
DecisionUnknown

Device Summary

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F is the device name listed in this FDA 510(k) record. The listed applicant is Potrero Medical, Inc.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221020. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F?

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Potrero Medical, Inc.. The 510(k) number is K221020.

When did Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F receive FDA 510(k) clearance?

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221020.

Who is the listed applicant for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F?

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

What is the FDA product code for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F?

The FDA product code for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F is EZL.

Other records listing Potrero Medical, Inc. 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.

K153655Accuryn Monitoring System

Related Devices (Code: EZL)

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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