510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLPClass II

High Intensity Ultrasound System For Prostate Tissue Ablation

21 CFR 876.4340 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PLP is the FDA product code for High Intensity Ultrasound System For Prostate Tissue Ablation, a class II device type, regulated under 21 CFR 876.4340. FDA's definition for this code reads: "Prostate tissue ablation". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PLP
Device name
High Intensity Ultrasound System For Prostate Tissue Ablation
FDA definition
Prostate tissue ablation
Regulation
21 CFR 876.4340
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
1

Clearances, product code PLP

By decision year
13 clearances under product code PLP with a decision year between 2015 and 2025, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PLP by decision year
YearClearances
20152
20161
20171
20181
20191
20201
20211
20221
20232
20241
20251

Applicants with the most clearances

Product code PLP
Applicants holding the most 510(k) clearances under product code PLP
ApplicantClearances
Profound Medical Inc.5
Edap Technomed Inc.4
Insightec, Ltd.2
Sonacare Medical, LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code