Product Code: ODA FDA class 2 21 CFR 876.1500

Endoscopic Central Control Unit

Gastroenterology, Urology

The Endoscopic Central Control Unit (product code ODA) is a gastroenterology and urology device used to control endoscopic and ancillary surgical equipment from one central location, via remote control, touch screen, or voice command, streamlining operation in the endoscopy suite or operating room. Integration of control functions improves workflow and reduces the need for manual equipment adjustments during procedures. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ODA
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232406	KARL STORZ OR1 SCB CONTROL (WU300)	Oct 03, 2023	Substantially Equivalent	Karl Storz SE & CO. KG
K221929	Smith+Nephew INTELLIO Tablet	Sep 06, 2022	Substantially Equivalent	Smith+Nephew
K203566	Tablet Application	May 13, 2021	Substantially Equivalent	Smith & Nephew
K192876	INTELLIO Tablet Application	Feb 27, 2020	Substantially Equivalent	Smith & Nephew
K153205	IDSS ForceTriad Control Module	Aug 01, 2016	Substantially Equivalent	Black Diamond Video, Inc.
K151282	core nova Complete Operating Room Endoscopy	Jan 12, 2016	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K111165	KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE	Jan 06, 2012	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K102763	SYSTEMS INTEGRATION	Feb 15, 2011	Substantially Equivalent	Olympus Medical Systems Corporation
K100345	SYSTEMS INTEGRATION MODEL: ENDOALPHA	Mar 22, 2010	Substantially Equivalent	Olympus Medical Systems Corporation
K083598	KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION	May 29, 2009	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K080410	KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522	Apr 09, 2008	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K070827	KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120	May 22, 2007	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K051613	MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3	Aug 15, 2005	Substantially Equivalent	Olympus Medical Systems Corporation
K041912	SCB/VALLEYLAB FORCE FX INTERFACE UNIT	Oct 25, 2004	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K020255	RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590	Sep 18, 2002	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K022270	MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA	Aug 14, 2002	Substantially Equivalent	Olympus Optical Co., Ltd.
K994231	SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)	Aug 10, 2000	Substantially Equivalent	Siemens Medical Corp.
K981993	OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA	Aug 21, 1998	Substantially Equivalent	The Olympus Optical Co.