510(k) clearances

Tulsa Pro System (Pad-105)

Profound Medical, Inc. · Gastroenterology, Urology

K240296Substantially EquivalentTraditionalPLP
Open FDA's page for this record
Third party flag
N
City
Mississauga
Advisory committee description
Gastroenterology, Urology
Address 1
2400 Skymark Ave. # 6
Statement or summary
Statement
Product code
PLP
Zip code
L4W 5K5
Applicant
Profound Medical, Inc.
Decision date
2024-05-09
Decision code
SESE
Country code
CA
Device name
Tulsa Pro System (Pad-105)
Advisory committee
GU
Contact
Golddy Kaur
K number
K240296
Date received
2024-02-01
Review advisory committee
GU
Postal code
L4W 5K5
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
High Intensity Ultrasound System For Prostate Tissue Ablation
Medical specialty description
Gastroenterology, Urology
Regulation number
876.4340
Device class
2
Registration number
3012604011, 3007126306, 2951226, 9612448, 1450662, 1319639, 1287394, 9615058
FEI number
3012604011, 3002806876, 3003105983, 3007126306, 1000138054, 1450662, 1287394, 3002132857
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.