The following data is part of a premarket notification filed by Uroplasty, Inc. with the FDA for Uroplasty Rigid Endoscpic Needles.
| Device ID | K121337 |
| 510k Number | K121337 |
| Device Name: | UROPLASTY RIGID ENDOSCPIC NEEDLES |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | UROPLASTY, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Contact | Emily Metcalfe |
| Correspondent | Emily Metcalfe 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 | 2012-05-03 |
| Decision Date | 2012-08-03 |
| Summary: | summary |