FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ENDO-MARYLAND DISSECTOR
K Number: K141794
·
Decision Nov 19, 2014
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
14
Review Days
140
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Basic Information
- Device Name
- ENDO-MARYLAND DISSECTOR
- K Number
- K141794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ovesco Endoscopy AG
- Date Received
- July 2, 2014
- Decision Date
- November 19, 2014
- Product Code
- KGE
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Ovesco Endoscopy AG
| K Number | Device Name | ||
|---|---|---|---|
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Dec 18, 2025 | Substantially Equivalent |
| K242586 | ArgoCap (200.52) | May 22, 2025 | Substantially Equivalent |
| 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 |