510(k) K132561
- Device
- NURO NEUROMODULATION SYSTEM
- Applicant
- ADVANCED URO-SOLUTIONS, INC.
- 510(k) number
- K132561
- Product code
- NAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-05
- Date received
- 2013-08-15
- Regulation
- 876.5310
- Classification name
- Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PENNY NORTHCUTT
- Address
- 717 Lakeglen Dr. Swanee GA US 30024 30024
FDA Registration Numbers#
- 3027578962
- 3021071765
- 3002647932
- 2183164
- 3018094310
- 2183613
- 3003477135
- 2182207
Source Documents#
Other 510(k) Records For Product Code NAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Avation Medical, Inc. | 2023-04-03 |
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021-03-19 |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Uroplasty, Inc. | 2010-10-21 |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Uroplasty, Inc. | 2007-08-20 |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Uroplasty, Inc. | 2006-07-03 |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Uroplasty, Inc. | 2005-10-17 |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Urosurge, Inc. | 2000-02-09 |
Legacy Summary#
summary
FDA Review#
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