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

Lithotriptor, Electro-Hydraulic

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

FFK is the FDA product code for Lithotriptor, Electro-Hydraulic, a class II device type, regulated under 21 CFR 876.4480. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
FFK
Device name
Lithotriptor, Electro-Hydraulic
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
61
Ingested recalls
21

Clearances, product code FFK

By decision year
61 clearances under product code FFK with a decision year between 1980 and 2025, 1989 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FFK by decision year
YearClearances
19801
19822
19832
19841
19851
19861
19871
19881
19895
19901
19912
19925
19932
19943
19952
19972
19984
19993
20001
20014
20051
20072
20102
20122
20133
20162
20191
20211
20231
20252

Applicants with the most clearances

Product code FFK
Applicants holding the most 510(k) clearances under product code FFK
ApplicantClearances
Northgate Technologies Inc.11
E.M.S. - Electro Medical Systems SA6
Cybersonics, Inc.5
Northgate Research, Inc.5
Richard Wolf Medical Instruments Corp.4
Candela Corporation3
Karl Storz Endoscopy-America, Inc.3
Med-Sonics Corp.3
Monaghan Medical Corp.3
Boston Scientific Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order