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FDA 510(k)

Tulsa-Pro System

K-Number: K202286 · 2020-09-16

ApplicantProfound Medical, Inc.
Decision Date2020-09-16
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tulsa-Pro System is a medical device manufactured by Profound Medical, Inc.. It received FDA 510(k) clearance on 2020-09-16 under approval number K202286. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tulsa-Pro System?

Tulsa-Pro System is a medical device that received FDA 510(k) clearance on 2020-09-16. It is manufactured by Profound Medical, Inc.. The 510(k) number is K202286.

When was Tulsa-Pro System approved by the FDA?

Tulsa-Pro System received FDA 510(k) clearance on 2020-09-16, under approval number K202286.

What company makes Tulsa-Pro System?

Tulsa-Pro System is manufactured by Profound Medical, Inc..

What is the FDA product code for Tulsa-Pro System?

The FDA product code for Tulsa-Pro System is PLP.

Other Devices by Profound Medical, Inc.

K191200TULSA-PRO System K211858TULSA-PRO System K230692TULSA-PRO System K240296Tulsa Pro System (Pad-105)

Related Devices (Code: PLP)

K160942SonablateSonacare Medical, LLC K172285Ablatherm FusionEdap Technomed, Inc. K172721FOCAL ONEEdap Technomed, Inc. K191200TULSA-PRO SystemProfound Medical, Inc. K212150Exablate Prostate SystemInsightec, Inc. K211858TULSA-PRO SystemProfound Medical, Inc.

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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