Karl Storz Scb/Conmed Esu Interface Module, Model 20091522
FDA 510(k) K080410 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK080410
Submission
- Device name
- Karl Storz Scb/Conmed Esu Interface Module, Model 20091522
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- February 14, 2008
- Decision date
- April 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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| 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 |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
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Questions and answers
When was Karl Storz Scb/Conmed Esu Interface Module, Model 20091522 cleared by the FDA?
Karl Storz Scb/Conmed Esu Interface Module, Model 20091522 (K080410) received a 510(k) decision of Substantially Equivalent on April 9, 2008, 55 days after the submission was received.
What is the product code of K080410?
The FDA product code is ODA – Endoscopic Central Control Unit, a Class II (moderate risk) device regulated under 21 CFR 876.1500.