510(k) K123337
- Device
- VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
- Applicant
- CALDERA MEDICAL
- 510(k) number
- K123337
- Product code
- OTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-02-21
- Date received
- 2012-10-31
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Medical specialty
- General & Plastic Surgery
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICKI GAIL
- Address
- 5171 Clareton Dr. Agoura Hills CA US 91301 91301
FDA Registration Numbers#
- 3003990090
- 2125050
- 3004859928
- 2183744
- 3014255023
- 2210968
- 3017102971
- 3014272734
- 3005099803
- 3002807314
- 2648650
- 3005636544
- 1000121056
- 3002294946
- 3007125295
- 3006082230
- 1048735
- 1018233
- 1061124
Source Documents#
Other 510(k) Records For Product Code OTO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171271 | Polyform Synthetic Mesh | Boston Scientific Corporation | 2017-12-15 |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015-04-06 |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015-04-06 |
| K140116 | RESTORELLE Y CONTOUR MESH | Coloplast A/S | 2014-02-12 |
| K132061 | RESTORELLE M, RESTORELLE XL | Coloplast Corp. | 2013-08-02 |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Caldera Medical, Inc. | 2013-04-25 |
| K123914 | RESTORELLE Y CONTOUR | Coloplast A/S | 2013-03-05 |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | Coloplast Corp. | 2012-12-18 |
| K122794 | UPSYLON Y MESH | Boston Scientific Corp | 2012-12-18 |
| K122440 | RESTORELLE L | Coloplast Corp. | 2012-11-19 |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | American Medical Systems | 2012-10-16 |
| K113205 | ARTISYN Y-SHAPED MESH | ETHICON, Inc. | 2012-06-11 |
| K112322 | RESTORELLE POLYPROPYLENE Y MESH | Coloplast A/S | 2012-05-17 |
| K120327 | VERTESSA | Caldera Medical, Inc. | 2012-05-10 |
| K101722 | ALYTE Y-MESH GRAFT | C.R. Bard, Inc. | 2011-04-01 |
Legacy Summary#
summary
FDA Review#
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