The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Hydrophilic Guidewire For Urological & Laparoscopic Use.
| Device ID | K060034 |
| 510k Number | K060034 |
| Device Name: | NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT Lexington, KY 40514 |
| Contact | Kaelyn B Hadley |
| Correspondent | Kaelyn B Hadley NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT Lexington, KY 40514 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-05 |
| Decision Date | 2006-02-28 |
| Summary: | summary |