Karl Storz SCB / Covidien Forcetriad Interface Module
FDA 510(k) K111165 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK111165
Submission
- Device name
- Karl Storz SCB / Covidien Forcetriad Interface Module
- Applicant
- KARL STORZ Endoscopy-America, Inc.
El Segundo, CA, US - Received
- April 26, 2011
- Decision date
- January 6, 2012
- 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.
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| K083598 | Karl Storz VOICE1 SCB R-Ui Speech Control ApplicationODA · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/29/2009SE |
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| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| 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 |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
Questions and answers
When was Karl Storz SCB / Covidien Forcetriad Interface Module cleared by the FDA?
Karl Storz SCB / Covidien Forcetriad Interface Module (K111165) received a 510(k) decision of Substantially Equivalent on January 6, 2012, 255 days after the submission was received.
What is the product code of K111165?
The FDA product code is ODA – Endoscopic Central Control Unit, a Class II (moderate risk) device regulated under 21 CFR 876.1500.