Ovesco Endoscopy AG
Ovesco Endoscopy AG has 0 FDA recalls, 3 inspections, 16 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 13, 2017 · NAI
- Latest 510(k)
- Oct 2, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 16 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 13, 2017 | Tubingen, Germany | Devices | No Action Indicated (NAI) | 3006696607 |
| Jul 13, 2017 | Baden-Wuerttemberg, Germany | Devices | No Action Indicated (NAI) | 3013456854 |
| Aug 29, 2013 | Tubingen, Germany | Devices | Voluntary Action Indicated (VAI) | 3006696607 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3006696607 | Tubingen, Germany | 2 | Jul 13, 2017 |
| FEI 3013456854 | Baden-Wuerttemberg, Germany | 1 | Jul 13, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K260487 | stentFIX System Set (100.50n) | Oct 2, 2026 |
| K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Sep 14, 2026 |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Dec 18, 2025 |
| K242586 | ArgoCap (200.52) | May 22, 2025 |
| K241858 | BARS Set (100.60) | Aug 26, 2024 |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Aug 11, 2022 |
| K200684 | gastroduodenal FTRD Set | Jun 2, 2020 |
| K183309 | stentfix OTSC System Set | Oct 22, 2019 |
| DEN160014 | remOVE System | Dec 22, 2017 |
| K170867 | FTRD System Set | Jul 25, 2017 |
| K153550 | FTRD System Set | Oct 12, 2016 |
| K150067 | OTSC Proctology | Sep 16, 2015 |
| K141790 | AQANIFE | Mar 6, 2015 |
| K141794 | ENDO-MARYLAND DISSECTOR | Nov 19, 2014 |
| K140923 | TRACTION POLYPECTOMY SNARE | Nov 18, 2014 |
| K101428 | OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET | Dec 1, 2010 |
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