FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
stentfix OTSC System Set
K Number: K183309
·
Decision Oct 22, 2019
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
14
Review Days
327
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Basic Information
- Device Name
- stentfix OTSC System Set
- K Number
- K183309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ovesco Endoscopy AG
- Date Received
- November 29, 2018
- Decision Date
- October 22, 2019
- Product Code
- PKL
- 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 |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKL), ordered by most recent decision date.
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
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FDA Class 2
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Hemoclip
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Taurus Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OTSCneo System Set (100.03n-14n, 100.27n-31n)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Hemoclip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dual Action Tissue Closure Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |