Video Endoscopy System, 3D Video Endoscopy System
FDA 510(k) K210116 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
510(k) numberK210116
Submission
- Device name
- Video Endoscopy System, 3D Video Endoscopy System
- Applicant
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Cixi, CN - Received
- January 19, 2021
- Decision date
- October 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
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| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
| K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)HET · Special | Olympus Winter & Ibe GmbH | 08/29/2019SE |
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Questions and answers
When was Video Endoscopy System, 3D Video Endoscopy System cleared by the FDA?
Video Endoscopy System, 3D Video Endoscopy System (K210116) received a 510(k) decision of Substantially Equivalent on October 13, 2021, 267 days after the submission was received.
What is the product code of K210116?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.