Data / Medical devices / United States / Ovesco Endoscopy USA
Ovesco Endoscopy USA: FDA-registered device maker in Cary, NC, United States, 13 510(k) clearances
Ovesco Endoscopy USA is registered with the FDA (registration 3008720584) in Cary, NC, United States. It lists 16 device types. The FDA files 13 510(k) clearances under its listings, the newest dated December 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008720584
- Address
- 15300 Weston Parkway Suite 101, Cary, NC, United States, 27513
- Owner or operator
- Ovesco Endoscopy (10031680)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 18, 1994
- Registered through
- 2026
- Brand names listed
- AWC, AWCduo, AqaNife, ArgoCap, BARS Anchor black, BARS Anchor silver, BARS Set (100.60), BougieCap and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2025 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| May 22, 2025 | K242586 | ArgoCap (200.52) | OCX | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| August 26, 2024 | K241858 | BARS Set (100.60) | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| August 11, 2022 | K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | PLL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| June 2, 2020 | K200684 | gastroduodenal FTRD Set | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| October 22, 2019 | K183309 | stentfix OTSC System Set | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| December 22, 2017 | DEN160014 | remOVE System | QAG | Unknown | Ovesco Endoscopy AG | accessdata.fda.gov |
| July 25, 2017 | K170867 | FTRD System Set | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| September 16, 2015 | K150067 | OTSC Proctology | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| March 6, 2015 | K141790 | AQANIFE | GEI | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| November 19, 2014 | K141794 | ENDO-MARYLAND DISSECTOR | KGE | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| November 18, 2014 | K140923 | TRACTION POLYPECTOMY SNARE | FDI | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
| December 1, 2010 | K101428 | OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET | PKL | Substantially Equivalent | Ovesco Endoscopy AG | accessdata.fda.gov |
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Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.