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

Mini Endoscope, Gastroenterology-Urology

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

ODF is the FDA product code for Mini Endoscope, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To examine and perform procedures in body cavities of the GI and GU tract. 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 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ODF
Device name
Mini Endoscope, Gastroenterology-Urology
FDA definition
To examine and perform procedures in body cavities of the GI and GU tract. 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
12
Ingested recalls
0

Clearances, product code ODF

By decision year
12 clearances under product code ODF with a decision year between 1988 and 2010, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ODF by decision year
YearClearances
19881
19912
19931
19941
19951
19971
20052
20092
20101

Applicants with the most clearances

Product code ODF
Applicants holding the most 510(k) clearances under product code ODF
ApplicantClearances
Boston Scientific Corporation3
Candela Corporation3
C-Link Micro Imaging, Inc.1
Five Star Medical, Inc.1
Lumenis Ltd1
Medical Laser, Inc.1
Origin Medsystems, Inc.1
Ovamed Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code