Ovesco Endoscopy AG: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Ovesco Endoscopy AG” (first 2010, latest 2026), plus 1 De Novo decision, across 7 product codes in 2 review panels. Median 510(k) review time under this name: 216 days. Since 2017 the median was 167 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 181 |
| 2015 | 2 | 246 |
| 2016 | 1 | 306 |
| 2017 | 1 | 124 |
| 2018 | 0 | — |
| 2019 | 1 | 327 |
| 2020 | 1 | 78 |
| 2021 | 0 | — |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 1 | 60 |
| 2025 | 2 | 238 |
| 2026 | 1 | 335 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ovesco Endoscopy AG took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | 9 | 9 |
| FDI | Snare, Flexible | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
| PLL | Submucosal Injection Agent | 1 | 1 |
| QAG | Endoscopic Electrosurgical Clip Cutting System | 1 | 0 |
Review panels
Most recent Ovesco Endoscopy AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | PKL | 2026-09-14 | 335 |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | PKL | 2025-12-18 | 210 |
| K242586 | ArgoCap (200.52) | OCX | 2025-05-22 | 265 |
| K241858 | BARS Set (100.60) | PKL | 2024-08-26 | 60 |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | PLL | 2022-08-11 | 90 |
| K200684 | gastroduodenal FTRD Set | PKL | 2020-06-02 | 78 |
| K183309 | stentfix OTSC System Set | PKL | 2019-10-22 | 327 |
| K170867 | FTRD System Set | PKL | 2017-07-25 | 124 |
| K153550 | FTRD System Set | PKL | 2016-10-12 | 306 |
| K150067 | OTSC Proctology | PKL | 2015-09-16 | 246 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160014 | De Novo | Endoscopic Electrosurgical Clip Cutting System | 2017-12-22 |
Recalls
openFDA lists no recalls under a recalling firm named Ovesco Endoscopy AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ovesco Endoscopy AG (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Ovesco Endoscopy AG?
FDA lists 14 510(k) clearances under the applicant name “Ovesco Endoscopy AG” (first 2010, latest 2026), plus 1 De Novo decision, across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ovesco Endoscopy AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ovesco Endoscopy AG is 216 days. Since 2017: 167 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ovesco Endoscopy AG?
The most frequent FDA product codes under this applicant name are PKL (Hemostatic Metal Clip For The Gi Tract, 9); FDI (Snare, Flexible, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 14 Ovesco Endoscopy AG clearances with predicates and recalls
- Run predicate analysis for product code PKL, Ovesco Endoscopy AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.