FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
K Number: K123028
·
Decision Apr 25, 2013
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
22
Applicant Total
22
Review Days
209
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Basic Information
- Device Name
- VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
- K Number
- K123028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caldera Medical, Inc.
- Date Received
- September 28, 2012
- Decision Date
- April 25, 2013
- Product Code
- OTO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTO), ordered by most recent decision date.
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RESTORELLE Y CONTOUR MESH
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RESTORELLE Y CONTOUR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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|---|---|---|---|
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| K192811 | BenestaTM Tissue Removal Device | Oct 23, 2020 | Substantially Equivalent |
| K192822 | Benesta Hysteroscope | Sep 9, 2020 | Substantially Equivalent |
| K193603 | Benesta Medical Sterilization Tray | Jul 20, 2020 | Substantially Equivalent |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Feb 7, 2020 | Substantially Equivalent |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | May 4, 2018 | Substantially Equivalent |
| 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 |