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

Lithotriptor, Ultrasonic

21 CFR 876.4480 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FEO is the FDA product code for Lithotriptor, Ultrasonic, a class II device type, regulated under 21 CFR 876.4480. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FEO
Device name
Lithotriptor, Ultrasonic
Regulation
21 CFR 876.4480
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
Yes
Ingested clearances
14
Ingested recalls
7

Clearances, product code FEO

By decision year
14 clearances under product code FEO with a decision year between 1984 and 2023, 2018 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FEO by decision year
YearClearances
19842
19851
19871
19921
19981
19991
20141
20171
20184
20231

Applicants with the most clearances

Product code FEO
Applicants holding the most 510(k) clearances under product code FEO
ApplicantClearances
E.M.S. - Electro Medical Systems SA5
Cybersonics, Inc.2
Fibra Sonics, Inc.2
Karl Storz Endoscopy-America, Inc.2
Cabot Medical Corp.1
Olympus Corp.1
Richard Wolf Medical Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order