FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ArgoCap (200.52)
K Number: K242586
·
Decision May 22, 2025
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
14
Review Days
265
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Basic Information
- Device Name
- ArgoCap (200.52)
- K Number
- K242586
- 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
- August 30, 2024
- Decision Date
- May 22, 2025
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K241858 | BARS Set (100.60) | Aug 26, 2024 | Substantially Equivalent |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Aug 11, 2022 | Substantially Equivalent |
| K200684 | gastroduodenal FTRD Set | Jun 2, 2020 | Substantially Equivalent |
| K183309 | stentfix OTSC System Set | Oct 22, 2019 | Substantially Equivalent |
| DEN160014 | remOVE System | Dec 22, 2017 | Unknown |
| 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 |