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

Colonoscope And Accessories, Flexible/Rigid

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

FDF is the FDA product code for Colonoscope And Accessories, Flexible/Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To examine or perform procedures in the colon or rectum 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 114 510(k) clearances under this code, the most recent dated , and 25 recalls.

Classification record

Product code
FDF
Device name
Colonoscope And Accessories, Flexible/Rigid
FDA definition
To examine or perform procedures in the colon or rectum 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
115
Ingested recalls
25

Clearances, product code FDF

By decision year
115 clearances under product code FDF with a decision year between 1976 and 2026, 2012 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code FDF by decision year
YearClearances
19761
19792
19801
19813
19821
19891
19901
19954
19965
19971
20002
20021
20042
20053
20061
20074
20082
20096
20104
20112
20127
20132
20146
20152
20167
20174
20187
20194
20204
20213
20225
20236
20242
20254
20265

Applicants with the most clearances

Product code FDF
Applicants holding the most 510(k) clearances under product code FDF
ApplicantClearances
Pentax Precision Instrument Corp.11
FUJIFILM Healthcare Americas Corporation8
MOTUS GI Medical Technologies Ltd.7
Olympus Medical Systems Corp.7
Avantis Medical Systems, Inc.6
Lumendi, LLC6
FUJIFILM Corporation5
Smart Medical Systems Ltd.5
PENTAX of America, Inc.4
GI View Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order