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

Choledochoscope And Accessories, Flexible/Rigid

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FBN is the FDA product code for Choledochoscope And Accessories, Flexible/Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
FBN
Device name
Choledochoscope And Accessories, Flexible/Rigid
FDA definition
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation
21 CFR 876.1500
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
No
Ingested clearances
43
Ingested recalls
9

Clearances, product code FBN

By decision year
43 clearances under product code FBN with a decision year between 1977 and 2026, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FBN by decision year
YearClearances
19771
19821
19901
19913
19922
19932
19942
19954
19961
19972
20051
20061
20083
20101
20121
20151
20161
20181
20191
20201
20234
20242
20253
20263

Applicants with the most clearances

Product code FBN
Applicants holding the most 510(k) clearances under product code FBN
ApplicantClearances
Olympus Medical Systems Corp.6
Boston Scientific Corporation4
Karl Storz Endoscopy-America, Inc.4
Pentax Precision Instrument Corp.3
Applied Laparoscopy2
Mirco-Tech (Nanjing) Co., Ltd.2
Olympus Corp.2
Richard Wolf Medical Instruments Corp.2
Shanghai Seegen Photoelectric Technology Co., Ltd2
Shenzhen Hugemed Medical Technical Development Co., Ltd2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order