The following data is part of a premarket notification filed by Surgitek with the FDA for Quadra-coil Ureteral Stent.
| Device ID | K946296 |
| 510k Number | K946296 |
| Device Name: | QUADRA-COIL URETERAL STENT |
| Classification | Stent, Ureteral |
| 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 | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1995-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925006577 | K946296 | 000 |
| 00821925005815 | K946296 | 000 |
| 00821925005471 | K946296 | 000 |
| 00821925005112 | K946296 | 000 |