The following data is part of a premarket notification filed by Uroplasty, Inc. with the FDA for Uroplasty Rigid Endoscopic Needle, Mrn-518.
| Device ID | K091391 |
| 510k Number | K091391 |
| Device Name: | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | UROPLASTY, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Contact | Michael Morrell |
| Correspondent | Michael Morrell UROPLASTY, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-06-30 |
| Summary: | summary |