← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PJH — Dynamic Rectal Control System
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
DEVICE CLASS
Class II
REGULATION
21 CFR 876.5930
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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