K233222
- 510(k) number
- K233222
- Device name
- Aygün Sterilization Container Systems
- Applicant
- Aygun Surgical Instruments Co., Inc. TR
- Product code
- KCT — Sterilization Wrap Containers, Trays, Cassettes & Ot
- Decision date
- 2023-12-12
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.