FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESARA MESH SLING, MODEL CAL-DS01
K Number: K072456
·
Decision May 8, 2008
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
15
Review Days
251
Basic Information
- Device Name
- DESARA MESH SLING, MODEL CAL-DS01
- K Number
- K072456
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CALDERA MEDICAL, INC.
- Date Received
- August 31, 2007
- Decision Date
- May 8, 2008
- Product Code
- OTN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | FDA class 2 | General, Plastic Surgery |
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Other Clearances by CALDERA MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162201 | Desara TV, Desara Blue TV | Jan 11, 2017 | Substantially Equivalent |
| K150016 | Vertessa Lite | Apr 6, 2015 | Substantially Equivalent |
| K150023 | Vertessa Lite Y-Mesh | Apr 6, 2015 | Substantially Equivalent |
| K132069 | DESARA MESH, DESARA BLUE | Sep 23, 2013 | Substantially Equivalent |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Apr 25, 2013 | Substantially Equivalent |
| K121928 | DESARA SL | Feb 19, 2013 | Substantially Equivalent |
| K120327 | VERTESSA | May 10, 2012 | Substantially Equivalent |
| K103418 | DESARA MINI | Nov 30, 2011 | Substantially Equivalent |
| K112609 | DESARA MESH | Sep 30, 2011 | Substantially Equivalent |
| K101462 | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH | Aug 16, 2010 | Substantially Equivalent |