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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
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Review Panel
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Review Panel
Gastroenterology and Urology
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General Hospital
Review Panel
Hematology
Review Panel
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Assisted Reproduction Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Prosthetic Devices
CFR Sub-Part
Clinical Chemistry Test Systems
CFR Sub-Part
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CFR Sub-Part
Miscellaneous
Miscellaneous
Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Obstetrical and Gynecological Therapeutic Devices
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Physical Medicine Prosthetic Devices
CFR Sub-Part
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CFR Sub-Part
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)
K
12
2440
RESTORELLE L
2
Cleared 510(K)
K
12
1805
AMS LARGE PORE POLYPROPHLENE MESH
2
Cleared 510(K)
K
11
3205
ARTISYN Y-SHAPED MESH
2
Cleared 510(K)
K
11
2322
RESTORELLE POLYPROPYLENE Y MESH
2
Cleared 510(K)
K
12
0327
VERTESSA
2
Cleared 510(K)
K
10
1722
ALYTE Y-MESH GRAFT
2
Cleared 510(K)
K
09
0739
BARD SACROCOLPOPEXY GRAFT
2
Cleared 510(K)
K
05
3361
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
2
Cleared 510(K)
K
05
1485
AMS PELVIC FLOOR REPAIR SYSTEM
2
Cleared 510(K)
K
05
1245
POLYFORM SYNTHETIC MESH
2
Cleared 510(K)
K
04
1632
MINIMESH POLYPROPYLENE MESH
2
Cleared 510(K)
K
01
3718
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
2
Cleared 510(K)
K
01
0931
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
2
Cleared 510(K)
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 2 June 2023 at 11:04 pm
OB
/
prosthetic-devices
/
OTO
/
K053361
View Source
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053361
510(k) Type
Special
Applicant
MPATHY MEDICAL DEVICES, LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/6/2006
Days to Decision
66 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
K
12
2440
RESTORELLE L
K
12
1805
AMS LARGE PORE POLYPROPHLENE MESH
K
11
3205
ARTISYN Y-SHAPED MESH
K
11
2322
RESTORELLE POLYPROPYLENE Y MESH
K
12
0327
VERTESSA
K
10
1722
ALYTE Y-MESH GRAFT
K
09
0739
BARD SACROCOLPOPEXY GRAFT
K
05
3361
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
K
05
1485
AMS PELVIC FLOOR REPAIR SYSTEM
K
05
1245
POLYFORM SYNTHETIC MESH
K
04
1632
MINIMESH POLYPROPYLENE MESH
K
01
3718
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
K
01
0931
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
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
/
K053361
View Source
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053361
510(k) Type
Special
Applicant
MPATHY MEDICAL DEVICES, LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/6/2006
Days to Decision
66 days
Submission Type
Summary