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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 the device name listed in this FDA 510(k) record. The listed applicant is Profound Medical, Inc.. It received FDA 510(k) clearance on 2022-09-06 under 510(k) 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. The listed applicant is Profound Medical, Inc.. The 510(k) number is K211858.

When did TULSA-PRO System receive FDA 510(k) clearance?

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

Who is the listed applicant for TULSA-PRO System?

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

What is the FDA product code for TULSA-PRO System?

The FDA product code for TULSA-PRO System is PLP.

Other records listing Profound 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.

K240296Tulsa Pro System (Pad-105)K230692TULSA-PRO SystemK202286Tulsa-Pro SystemK191200TULSA-PRO System

Related Devices (Code: PLP)

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.

K251910Focal One®Edap Technomed, Inc.K240296Tulsa Pro System (Pad-105)Profound Medical, Inc.K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0Insightec, Ltd.K230692TULSA-PRO SystemProfound Medical, Inc.K212150Exablate Prostate SystemInsightec, Inc.K202286Tulsa-Pro SystemProfound Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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