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FDA 510(k)

TULSA-PRO System

K-Number: K211858 · 2022-09-06

ApplicantProfound Medical, Inc.
Decision Date2022-09-06
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 2022-09-06 under approval number K211858. 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 2022-09-06. It is manufactured by Profound Medical, Inc.. The 510(k) number is K211858.

When was TULSA-PRO System approved by the FDA?

TULSA-PRO System received FDA 510(k) clearance on 2022-09-06, under approval number K211858.

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 K202286Tulsa-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. K202286Tulsa-Pro SystemProfound Medical, Inc. K212150Exablate Prostate SystemInsightec, 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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