FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Pure Vu
K Number: K160015
·
Decision Sep 22, 2016
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
111
Applicant Total
7
Review Days
262
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Basic Information
- Device Name
- Pure Vu
- K Number
- K160015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Motus GI Medical Technologies , Ltd.
- Date Received
- January 4, 2016
- Decision Date
- September 22, 2016
- Product Code
- FDF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Motus GI Medical Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232922 | Pure-Vu EVS System | Oct 20, 2023 | Substantially Equivalent |
| K220007 | Pure-Vu EVS System | Feb 10, 2022 | Substantially Equivalent |
| K210981 | Pure Vu System | Apr 29, 2021 | Substantially Equivalent |
| K191220 | Pure Vu System | Jun 6, 2019 | Substantially Equivalent |
| K181437 | Pure Vu System | Jun 21, 2018 | Substantially Equivalent |
| K173392 | Pure-Vu System | Dec 12, 2017 | Substantially Equivalent |