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

System, Water Jet Catheter, Renal

21 CFR 876.4650 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FFE is the FDA product code for System, Water Jet Catheter, Renal, a class II device type, regulated under 21 CFR 876.4650. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FFE
Device name
System, Water Jet Catheter, Renal
Regulation
21 CFR 876.4650
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code FFE

By decision year
1 clearance under product code FFE with a decision year between 1997 and 1997, 1997 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FFE by decision year
YearClearances
19971

Applicants with the most clearances

Product code FFE
Applicants holding the most 510(k) clearances under product code FFE
ApplicantClearances
OLYMPUS Corporation of the Americas1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FFE.