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

Dislodger, Stone, Flexible

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

FGO is the FDA product code for Dislodger, Stone, Flexible, a class II device type, regulated under 21 CFR 876.4680. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
FGO
Device name
Dislodger, Stone, Flexible
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
19
Ingested recalls
3

Clearances, product code FGO

By decision year
19 clearances under product code FGO with a decision year between 1977 and 2000, 1992 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FGO by decision year
YearClearances
19771
19893
19903
19924
19931
19942
19951
19962
19971
20001

Applicants with the most clearances

Product code FGO
Applicants holding the most 510(k) clearances under product code FGO
ApplicantClearances
Annex Medical, Inc.4
Boston Scientific Corporation4
Northgate Research, Inc.2
Surgitek2
C.N. Technocrats1
Critikon Company, LLC1
Jet Far Industries, Inc.1
Scion Cardiovascular, Inc.1
Thai Fuji Latex Co., Ltd.1
United States Endoscopy Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order