FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
K Number: K221385
·
Decision Aug 11, 2022
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
- K Number
- K221385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ovesco Endoscopy AG
- Date Received
- May 13, 2022
- Decision Date
- August 11, 2022
- Product Code
- PLL
- 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 |
|---|---|---|---|
| PLL | Submucosal Injection Agent | FDA class 2 | Gastroenterology, Urology |
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| K170867 | FTRD System Set | Jul 25, 2017 | Substantially Equivalent |
| K153550 | FTRD System Set | Oct 12, 2016 | Substantially Equivalent |
| K150067 | OTSC Proctology | Sep 16, 2015 | Substantially Equivalent |
| K141790 | AQANIFE | Mar 6, 2015 | Substantially Equivalent |