Modification to Olympus Integrated Endosurgery System Endoalpha
FDA 510(k) K022270 · Olympus Optical Co., Ltd.
510(k) numberK022270
Submission
- Device name
- Modification to Olympus Integrated Endosurgery System Endoalpha
- Applicant
- Olympus Optical Co., Ltd.
Melville, NY, US - Received
- July 15, 2002
- Decision date
- August 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODA – Endoscopic Central Control Unit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Other 510(k)s with product code ODA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232406 | Karl Storz OR1 SCB Control (WU300)ODA · Traditional | Karl Storz SE & CO. KG | 10/03/2023SE |
| K221929 | Smith+Nephew INTELLIO TabletODA · Traditional | Smith+Nephew | 09/06/2022SE |
| K203566 | Tablet ApplicationODA · Traditional | Smith & Nephew | 05/13/2021SE |
| K192876 | INTELLIO Tablet ApplicationODA · Traditional | Smith & Nephew | 02/27/2020SE |
| K153205 | IDSS ForceTriad Control ModuleODA · Traditional | Black Diamond Video, Inc. | 08/01/2016SE |
| K151282 | core nova Complete Operating Room EndoscopyODA · Traditional | Richard Wolf Medical Instruments Corp. | 01/12/2016SE |
| K111165 | Karl Storz SCB / Covidien Forcetriad Interface ModuleODA · Special | KARL STORZ Endoscopy-America, Inc. | 01/06/2012SE |
| K102763 | Systems IntegrationODA · Special | Olympus Medical Systems Corporation | 02/15/2011SE |
| K100345 | Systems Integration Model: EndoalphaODA · Special | Olympus Medical Systems Corporation | 03/22/2010SE |
| K083598 | Karl Storz VOICE1 SCB R-Ui Speech Control ApplicationODA · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/29/2009SE |
More from KARL STORZ Endoscopy-America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…EOQ · Traditional | 10/16/2003SE |
| K032066 | Sonosurg SystemLFL · Traditional | 10/03/2003SE |
| K031305 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 09/23/2003SE |
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | 07/24/2003SE |
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | 07/16/2003SE |
| K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8ODG · Traditional | 05/09/2003SE |
| K030194 | XUES-41 Endoscopic Electrosurgical UnitKNS · Traditional | 03/24/2003SE |
| K024138 | Heat Scissors Generator Set and Heat Scissors HandpieceGEI · Traditional | 03/12/2003SE |
| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
| K021852 | Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesGEI · Traditional | 02/11/2003SE |
Questions and answers
When was Modification to Olympus Integrated Endosurgery System Endoalpha cleared by the FDA?
Modification to Olympus Integrated Endosurgery System Endoalpha (K022270) received a 510(k) decision of Substantially Equivalent on August 14, 2002, 30 days after the submission was received.
What is the product code of K022270?
The FDA product code is ODA – Endoscopic Central Control Unit, a Class II (moderate risk) device regulated under 21 CFR 876.1500.