510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FDSClass II

Gastroscope And Accessories, Flexible/Rigid

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

FDS is the FDA product code for Gastroscope 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 stomach. 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 78 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
FDS
Device name
Gastroscope And Accessories, Flexible/Rigid
FDA definition
To examine or perform procedures in the stomach. 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
79
Ingested recalls
12

Clearances, product code FDS

By decision year
79 clearances under product code FDS with a decision year between 1983 and 2026, 2025 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code FDS by decision year
YearClearances
19831
19841
19851
19931
19951
19963
19973
19981
19991
20001
20012
20022
20031
20041
20061
20072
20101
20111
20123
20132
20142
20152
20161
20171
20186
20195
20202
20215
20222
20233
20245
20258
20267

Applicants with the most clearances

Product code FDS
Applicants holding the most 510(k) clearances under product code FDS
ApplicantClearances
FUJIFILM Corporation15
FUJIFILM Healthcare Americas Corporation9
Pentax Precision Instrument Corp.7
PENTAX of America, Inc.6
Evoendo, Inc.4
Olympus Optical Co., Ltd.4
OLYMPUS Corporation of the Americas3
Olympus Medical Systems Corp.3
Ambu A/S2
Easyglide, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order