Data / Medical devices / Turkey / Aygun Surgical Instruments Co.,inc.
Aygun Surgical Instruments Co.,inc.: FDA-registered device maker in Kutlukent, Samsun, Turkey, 1 510(k) clearance
Aygun Surgical Instruments Co.,inc. is registered with the FDA (registration 3006113180) in Kutlukent, Samsun, Turkey. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006113180
- Address
- Organize Sanayi Bolgesi, Kutlukent, Samsun, Turkey, 55330
- Owner or operator
- AYGUN SURGICAL INSTRUMENTS CO.,INC. (9089161)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 28, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 12, 2023 | K233222 | Aygün Sterilization Container Systems | KCT | Substantially Equivalent | Aygun Surgical Instruments Co., Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2023. 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.