The following data is part of a premarket notification filed by Solace Therapeutics with the FDA for Vesair Cystoscopic Sheath.
| Device ID | K162356 |
| 510k Number | K162356 |
| Device Name: | Vesair Cystoscopic Sheath |
| Classification | Accessories, Catheter, G-u |
| Applicant | Solace Therapeutics 135 Newbury St Framingham, MA 01701 |
| Contact | William Gruber |
| Correspondent | William Gruber Solace Therapeutics 135 Newbury St Framingham, MA 01701 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2017-03-02 |
| Summary: | summary |