Vsu - Visionsense Stereoscopic Vision System
FDA 510(k) K081102 · Visionsense, Ltd.
510(k) numberK081102
Submission
- Device name
- Vsu - Visionsense Stereoscopic Vision System
- Applicant
- Visionsense, Ltd.
Washington, DC, US - Received
- April 17, 2008
- Decision date
- May 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
More from Hjy Smart Medical Device Co., Ltd.
| 510(k) | Device | Decision |
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| K223020 | VS3-Iridium System (VS3-IR)OWN · Special | 10/28/2022SE |
| K210265 | VS3 Iridium SytemOWN · Traditional | 11/22/2021SE |
| K171208 | Trans-anal IntroducerFED · Traditional | 02/05/2018SE |
| K153548 | VS3 Stereoscopic High Definition Vision SystemHRX · Traditional | 02/22/2016SE |
| K152204 | VS3-IR systemOWN · Traditional | 10/28/2015SE |
| K150018 | VS3-IR-MMS SystemOWN · Traditional | 06/17/2015SE |
| K141002 | VS3 Stereoscopic High Definition Vision SystemHRX · Traditional | 06/26/2014SE |
| K131434 | VS3 Stereoscopic High Definition Vision SystemGWG · Special | 07/16/2013SE |
| K123467 | VS3GCJ · Special | 04/17/2013SE |
| K082355 | Visionsense Stereoscopic Vision SystemHRX · Traditional | 12/15/2008SE |
Questions and answers
When was Vsu - Visionsense Stereoscopic Vision System cleared by the FDA?
Vsu - Visionsense Stereoscopic Vision System (K081102) received a 510(k) decision of Substantially Equivalent on May 29, 2008, 42 days after the submission was received.
What is the product code of K081102?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.