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

Dislodger, Stone, Basket, Ureteral, Metal

21 CFR 876.4680 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FFL is the FDA product code for Dislodger, Stone, Basket, Ureteral, Metal, a class II device type, regulated under 21 CFR 876.4680. As of , FDA records hold 52 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
FFL
Device name
Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
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
52
Ingested recalls
10

Clearances, product code FFL

By decision year
52 clearances under product code FFL with a decision year between 1979 and 2019, 1986 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code FFL by decision year
YearClearances
19791
19801
19811
19831
19841
19853
19868
19875
19893
19902
19912
19924
19931
19945
19954
19962
19972
20021
20051
20081
20111
20171
20191

Applicants with the most clearances

Product code FFL
Applicants holding the most 510(k) clearances under product code FFL
ApplicantClearances
Annex Medical, Inc.10
Van-Tec, Inc.10
Boston Scientific Corporation2
C.R. Bard Inc2
OLYMPUS Corporation of the Americas2
Percutaneous Systems, Inc.2
American Edwards Laboratories1
American Medical Systems, Inc.1
Angiomed U.S., Inc.1
Calcula Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 91 companies shown, in name order