The following data is part of a premarket notification filed by Turbett Surgical Inc. with the FDA for Turbett Instrument Pod.
| Device ID | K202593 |
| 510k Number | K202593 |
| Device Name: | Turbett Instrument Pod |
| Classification | Wrap, Sterilization |
| Applicant | Turbett Surgical Inc. 125 Tech Park Drive Rochester, NY 14625 |
| Contact | Rob Turbett |
| Correspondent | David Furr FDC Services 8708 Capehart Cove Austin, TX 78733 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-05-19 |