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

Dynamic Rectal Control System

21 CFR 876.5930 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PJH is the FDA product code for Dynamic Rectal Control System, a class II device type, regulated under 21 CFR 876.5930. FDA's definition for this code reads: "Intended to treat fecal incontinence by controlling the size of the rectal lumen". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PJH
Device name
Dynamic Rectal Control System
FDA definition
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
Regulation
21 CFR 876.5930
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
2
Ingested recalls
0

Clearances, product code PJH

By decision year
2 clearances under product code PJH with a decision year between 2015 and 2015, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PJH by decision year
YearClearances
20152

Applicants with the most clearances

Product code PJH
Applicants holding the most 510(k) clearances under product code PJH
ApplicantClearances
Pelvalon2

Companies listing this code with FDA

Companies whose registered establishments list this code