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

Urethral Insert With Pump For Bladder Drainage

21 CFR 876.5140 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PIH is the FDA product code for Urethral Insert With Pump For Bladder Drainage, a class II device type, regulated under 21 CFR 876.5140. FDA's definition for this code reads: "The device is intended to empty urine from the bladder under patient control". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PIH
Device name
Urethral Insert With Pump For Bladder Drainage
FDA definition
The device is intended to empty urine from the bladder under patient control.
Regulation
21 CFR 876.5140
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PIH

By decision year
1 clearance under product code PIH with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PIH by decision year
YearClearances
20141

Applicants with the most clearances

Product code PIH
Applicants holding the most 510(k) clearances under product code PIH
ApplicantClearances
Vesiflo, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code