Tulsa Pro System (Pad-105)
K-Number: K240296 · 2024-05-09
ApplicantProfound Medical, Inc.
Decision Date2024-05-09
Product CodePLP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Tulsa Pro System (Pad-105) is a medical device manufactured by Profound Medical, Inc.. It received FDA 510(k) clearance on 2024-05-09 under approval number K240296. 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 (Pad-105)?
Tulsa Pro System (Pad-105) is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Profound Medical, Inc.. The 510(k) number is K240296.
When was Tulsa Pro System (Pad-105) approved by the FDA?
Tulsa Pro System (Pad-105) received FDA 510(k) clearance on 2024-05-09, under approval number K240296.
What company makes Tulsa Pro System (Pad-105)?
Tulsa Pro System (Pad-105) is manufactured by Profound Medical, Inc..
What is the FDA product code for Tulsa Pro System (Pad-105)?
The FDA product code for Tulsa Pro System (Pad-105) is PLP.
Other Devices by Profound Medical, Inc.
Related Devices (Code: PLP)
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.