Data / Medical devices / United States / Omec Medical NV Inc
Omec Medical NV Inc: FDA-registered device maker in Reno, NV, United States, 1 510(k) clearance
Omec Medical NV Inc is registered with the FDA (registration 3020142503) in Reno, NV, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 22, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020142503
- Address
- 5690 Riggins CT, Reno, NV, United States, 89502
- Owner or operator
- OMEC Medical NV Inc. (10082628)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 27, 2024
- Registered through
- 2026
- Brand names listed
- 690 Laparoscope, 10 mm, 0 deg, 33 cm, 690 Laparoscope, 10 mm, 30 deg, 33 cm, 690 Laparoscope, 5.4 mm, 0 deg, 30 cm, 690 Laparoscope, 5.4 mm, 30 deg, 30 cm, SPY Bariatric Laparoscope, Autoclavable, 10mm x 0, 45cm, SPY Bariatric Laparoscope, Autoclavable, 10mm x 30, 45cm, SPY Bariatric Laparoscope, Autoclavable, 10mm x 45, 45cm, SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 0, 45cm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| June 22, 2020 | K201151 | O-Mec 690 Series Laparoscopes | GCJ | Substantially Equivalent | Omec Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 22, 2020. 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.