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

Prosthesis, Penis, Inflatable

21 CFR 876.3350 / Gastroenterology, Urology
FDA source (opens on fda.gov)

JCW is the FDA product code for Prosthesis, Penis, Inflatable, a class III device type, regulated under 21 CFR 876.3350. FDA's definition for this code reads: "PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))". As of , FDA records hold no 510(k) clearances under this code and 19 recalls.

Classification record

Product code
JCW
Device name
Prosthesis, Penis, Inflatable
FDA definition
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Regulation
21 CFR 876.3350
Device class
Class III
Review panel
Gastroenterology, Urology
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
19

Companies listing this code with FDA

Companies whose registered establishments list this code