The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack.
| Device ID | K191416 |
| 510k Number | K191416 |
| Device Name: | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-28 |
| Decision Date | 2020-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000971 | K191416 | 000 |
| 00890594000957 | K191416 | 000 |