The following data is part of a premarket notification filed by Uroplasty, Inc. with the FDA for Urgent Pc Stimulator; Urgent Pc Lead Set.
| Device ID | K101847 |
| 510k Number | K101847 |
| Device Name: | URGENT PC STIMULATOR; URGENT PC LEAD SET |
| Classification | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| 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 | NAM |
| CFR Regulation Number | 876.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-10-21 |
| Summary: | summary |