K250011
- 510(k) number
- K250011
- Device name
- Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
- Applicant
- Turbett Surgical NY · US
- Product code
- FRG — Wrap, Sterilization
- Decision date
- 2025-04-04
- Date received
- 2025-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250011.pdf
Official FDA record: K250011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.