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Innolitics
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OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
2
Product Code
K
17
1271
Polyform Synthetic Mesh
2
Cleared 510(K)
K
15
0023
Vertessa Lite Y-Mesh
2
Cleared 510(K)
K
15
0016
Vertessa Lite
2
Cleared 510(K)
K
14
0116
RESTORELLE Y CONTOUR MESH
2
Cleared 510(K)
K
13
2061
RESTORELLE M, RESTORELLE XL
2
Cleared 510(K)
K
12
3028
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
2
Cleared 510(K)
K
12
3914
RESTORELLE Y CONTOUR
2
Cleared 510(K)
K
12
3337
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
2
Cleared 510(K)
K
12
2968
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
2
Cleared 510(K)
K
12
2794
UPSYLON Y MESH
2
Cleared 510(K)
Show All 23 Submissions
PAJ
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
2
Product Code
Therapeutic Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
OB
/
prosthetic-devices
/
OTO
/
K122794
View Source
UPSYLON Y MESH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122794
510(k) Type
Traditional
Applicant
BOSTON SCIENTIFIC CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/2012
Days to Decision
97 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Assisted Reproduction Devices
Cardiovascular Monitoring Devices
Cardiovascular Prosthetic Devices
Clinical Chemistry Test Systems
Diagnostic Devices
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Monitoring Devices
Obstetrical and Gynecological Prosthetic Devices
Obstetrical and Gynecological Surgical Devices
Obstetrical and Gynecological Therapeutic Devices
Physical Medicine Prosthetic Devices
Prosthetic Devices
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
K
17
1271
Polyform Synthetic Mesh
K
15
0023
Vertessa Lite Y-Mesh
K
15
0016
Vertessa Lite
K
14
0116
RESTORELLE Y CONTOUR MESH
K
13
2061
RESTORELLE M, RESTORELLE XL
K
12
3028
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
K
12
3914
RESTORELLE Y CONTOUR
K
12
3337
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
K
12
2968
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K
12
2794
UPSYLON Y MESH
Show All 23 Submissions
PAJ
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Therapeutic Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
prosthetic-devices
/
OTO
/
K122794
View Source
UPSYLON Y MESH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122794
510(k) Type
Traditional
Applicant
BOSTON SCIENTIFIC CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/2012
Days to Decision
97 days
Submission Type
Summary