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

Enteroscope And Accessories

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

FDA is the FDA product code for Enteroscope And Accessories, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To provide visualization and perform various procedures within the small intestine. 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...". As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FDA
Device name
Enteroscope And Accessories
FDA definition
To provide visualization and perform various procedures within the small intestine. 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
20
Ingested recalls
0

Clearances, product code FDA

By decision year
20 clearances under product code FDA with a decision year between 1981 and 2026, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FDA by decision year
YearClearances
19811
19842
19911
20001
20031
20041
20062
20081
20151
20192
20201
20211
20232
20241
20251
20261

Applicants with the most clearances

Product code FDA
Applicants holding the most 510(k) clearances under product code FDA
ApplicantClearances
FUJIFILM Healthcare Americas Corporation5
FUJIFILM Corporation3
Aspero Medical, Inc.2
American Mcgaw1
Boddingtons Plastics, Ltd.1
Fujifilm Corporaton1
Olympus Corp.1
Olympus Medical Systems Corp.1
Olympus Opto-Electronics Co., Ltd.1
Setma, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order