K250011 is an FDA 510(k) clearance for the Turbett Surgical Instrument Pod (TS1500). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Turbett Surgical (Henrietta, US). The FDA issued a Cleared decision on April 4, 2025, 92 days after receiving the submission on January 2, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K250011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2025 |
| Decision Date | April 04, 2025 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |