The following data is part of a premarket notification filed by Surgitek with the FDA for Helical Stone/flatwire Stone Baskets.
| Device ID | K933260 |
| 510k Number | K933260 |
| Device Name: | HELICAL STONE/FLATWIRE STONE BASKETS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-06 |
| Decision Date | 1994-01-11 |