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

Duodenoscope And Accessories, Flexible/Rigid

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

FDT is the FDA product code for Duodenoscope And Accessories, Flexible/Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 38 recalls.

Classification record

Product code
FDT
Device name
Duodenoscope And Accessories, Flexible/Rigid
FDA definition
To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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
35
Ingested recalls
38

Clearances, product code FDT

By decision year
35 clearances under product code FDT with a decision year between 1983 and 2026, 2019 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FDT by decision year
YearClearances
19831
19941
19963
19981
20021
20041
20081
20091
20111
20161
20172
20183
20195
20204
20212
20221
20242
20252
20262

Applicants with the most clearances

Product code FDT
Applicants holding the most 510(k) clearances under product code FDT
ApplicantClearances
PENTAX of America, Inc.9
Olympus Medical Systems Corp.8
FUJIFILM Corporation5
Pentax Precision Instrument Corp.3
Boston Scientific Corporation2
FUJIFILM Healthcare Americas Corporation2
Ambu A/S1
Ambu Innovation GmbH1
Karl Storz Endoscopy-America, Inc.1
OLYMPUS Corporation of the Americas1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order