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

Snare, Flexible

21 CFR 876.4300 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FDI is the FDA product code for Snare, Flexible, a class II device type, regulated under 21 CFR 876.4300. As of , FDA records hold 63 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
FDI
Device name
Snare, Flexible
Regulation
21 CFR 876.4300
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
63
Ingested recalls
18

Clearances, product code FDI

By decision year
63 clearances under product code FDI with a decision year between 1985 and 2026, 2014 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FDI by decision year
YearClearances
19851
19892
19903
19912
19922
19932
19943
19953
19962
19972
19991
20001
20011
20022
20041
20051
20082
20091
20111
20121
20133
20145
20153
20161
20171
20184
20193
20202
20211
20224
20231
20261

Applicants with the most clearances

Product code FDI
Applicants holding the most 510(k) clearances under product code FDI
ApplicantClearances
Boston Scientific Corporation10
United States Endoscopy Group, Inc.10
Horizons Intl. Corp.3
Cox Medical Ent., Inc.2
Hangzhou AGS MedTech Co., Ltd.2
Medi-Globe GmbH2
Micro-Tech (Nanjing) Co., Ltd.2
Mill-Rose Laboratory2
Wilson-Cook Medical Inc.2
Annex Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order