ODAClass II

Endoscopic Central Control Unit

21 CFR 876.1500 / Gastroenterology, Urology

ODA is the FDA product code for Endoscopic Central Control Unit, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command". As of 2026-09-10, FDA records hold 18 510(k) clearances under this code, the most recent dated 2023-10-03, and no recalls.

Classification record

Product code: ODA
Device name: Endoscopic Central Control Unit
FDA definition: To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
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: 18
Ingested recalls: 0

Clearances, product code ODA

By decision year

18 clearances under product code ODA with a decision year between 1998 and 2023, 2002 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code ODA by decision year
Year	Clearances
1998	1
2000	1
2002	2
2004	1
2005	1
2007	1
2008	1
2009	1
2010	1
2011	1
2012	1
2016	2
2020	1
2021	1
2022	1
2023	1

Applicants with the most clearances

Product code ODA

Applicants holding the most 510(k) clearances under product code ODA
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	5
Olympus Medical Systems Corp.	3
Olympus Optical Co., Ltd.	2
Richard Wolf Medical Instruments Corp.	2
Smith & Nephew, Inc.	2
Black Diamond Video, Inc.	1
Karl Storz SE & Co. KG	1
Siemens Medical Corp.	1
Smith+Nephew	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order