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by
Innolitics
Anesthesiology
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Review Panel
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Review Panel
Obstetrical and Gynecological
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Assisted Reproduction Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
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CFR Sub-Part
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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
CFR Sub-Part
HDO
Valve, Tubal Occlusion
3
Product Code
HDR
Cap, Cervical
2
Product Code
HDT
Device, Intrauterine, Contraceptive And Introducer
3
Product Code
HDW
Diaphragm, Contraceptive (And Accessories)
2
Product Code
HEB
Tampon, Menstrual, Unscented
2
Product Code
HEC
Insufflator, Vaginal
1
Product Code
HED
Douche Apparatus, Vaginal, Therapeutic
1
Product Code
HEE
Set, Anesthesia, Paracervical
2
Product Code
HEG
Set, Anesthesia, Pudendal
2
Product Code
HEH
Chamber, Decompression, Abdominal
3
Product Code
HFY
Band, Tubal Occlusion
3
Product Code
HGB
Clip, Tubal Occlusion
3
Product Code
HGF
Source, Abortion Unit, Vacuum
2
Product Code
HGG
Controller, Abortion Unit, Vacuum
2
Product Code
HGH
Cannula, Suction, Uterine
2
Product Code
HGX
Pump, Breast, Powered
2
Product Code
HGY
Pump, Breast, Non-Powered
1
Product Code
HGZ
Heater, Perineal, Direct Contact
2
Product Code
HHA
Heater, Perineal, Radiant, Non-Contact
2
Product Code
HHD
Pad, Menstrual, Unscented
1
Product Code
HHE
Cup, Menstrual
2
Product Code
HHI
System, Abortion, Vacuum
2
Product Code
HHL
Pad, Menstrual, Scented
2
Product Code
HHQ
System, Abortion, Metreurynter-Balloon
3
Product Code
HHS
Transcervical Contraceptive Tubal Occlusion Device
3
Product Code
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
3
Product Code
HIL
Tampon, Menstrual, Scented, Deodorized
2
Product Code
HIS
Condom
2
Product Code
KND
Heater, Perineal
2
Product Code
KNE
Set, Anesthesia, Obstetric
2
Product Code
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
3
Product Code
KXQ
Vibrator For Therapeutic Use, Genital
2
Product Code
LTZ
Condom With Nonoxynol-9
2
Product Code
LZL
Micro-Condom
3
Product Code
MBU
Single-Use Internal Condom
2
Product Code
MFD
Cannula, Intrauterine Insemination
2
Product Code
NUR
Pad, Interlabial
1
Product Code
MOL
Condom, Synthetic
2
Product Code
MSC
Barrier, Std, Oral Sex
2
Product Code
NBV
Device, Engorgement, Clitoral
2
Product Code
NRC
Pads, Menstrual, Scented-Deodorized
1
Product Code
NUC
Lubricant, Personal
2
Product Code
NUQ
Pad, Menstrual, Reusable
1
Product Code
OBB
Kit, Conception-Assist, Home Use
2
Product Code
OBY
Condom, Female, Animal Tissue
3
Product Code
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
2
Product Code
OHH
Breast Pump Kit
2
Product Code
OKW
Seminal Fluid Collection Kit
2
Product Code
OOA
Hemorrhoid Prevention Pressure Wedge
2
Product Code
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
K
12
2459
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
3
Cleared 510(K)
K
12
1612
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
3
Cleared 510(K)
K
11
2842
AMS ELEVATE PC
3
Cleared 510(K)
K
10
3426
LITE PELVIC FLOOR REPAIR KITS
3
Cleared 510(K)
K
11
2386
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
3
Cleared 510(K)
K
10
2815
SURELIFT PROLAPSE SYSTEM
3
Cleared 510(K)
K
11
1118
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
3
Cleared 510(K)
K
09
2207
RESTORELLE POLYPROPYLENE MESH
3
Cleared 510(K)
K
09
1131
PELVIC FLOOR REPAIR SYSTEM
3
Cleared 510(K)
K
08
3499
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
3
Cleared 510(K)
K
09
0713
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
3
Cleared 510(K)
K
08
3722
ASCEND
3
Cleared 510(K)
K
08
3839
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
3
Cleared 510(K)
K
08
2677
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
3
Cleared 510(K)
K
08
2387
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
3
Cleared 510(K)
K
08
2730
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
3
Cleared 510(K)
K
08
1710
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
3
Cleared 510(K)
K
08
2571
AVAULTA SUPPORT SYSTEM
3
Cleared 510(K)
K
08
1048
PINNACLE PELVIC FLOOR REPAIR KIT II
3
Cleared 510(K)
K
07
1512
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
3
Cleared 510(K)
K
08
0185
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
3
Cleared 510(K)
K
07
2951
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
3
Cleared 510(K)
K
07
1957
PINNACLE PELVIC FLOOR REPAIR KITS
3
Cleared 510(K)
K
06
3712
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
3
Cleared 510(K)
K
06
3562
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
3
Cleared 510(K)
K
05
3414
MENTOR NOVASILK MESH
3
Cleared 510(K)
K
05
1503
UGYTEX SUAL KNIT MESH
3
Cleared 510(K)
K
04
0623
AMS PERIGEE SYSTEM
3
Cleared 510(K)
K
04
0537
AMS APOGEE VAULT SUSPENSION SYSTEM
3
Cleared 510(K)
K
04
0521
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
3
Cleared 510(K)
K
03
3636
AMS LARGE PORE POLYPROPYLENE MESH
3
Cleared 510(K)
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
2
Product Code
PVT
Maternity Kit
1
Product Code
PVU
Obstetrical Anesthesia Kit
2
Product Code
PVV
Paracervical Anesthesia Kit
2
Product Code
PVW
Pudendal Anesthesia Kit
2
Product Code
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
1
Product Code
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
2
Product Code
QPD
Personal Lubricant Ring
2
Product Code
Physical Medicine Prosthetic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
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
/
obstetrical-and-gynecological-therapeutic-devices
/
OTP
/
K082571
View Source
AVAULTA SUPPORT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082571
510(k) Type
Special
Applicant
C.R. BARD, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/30/2008
Days to Decision
25 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
HDO
Valve, Tubal Occlusion
HDR
Cap, Cervical
HDT
Device, Intrauterine, Contraceptive And Introducer
HDW
Diaphragm, Contraceptive (And Accessories)
HEB
Tampon, Menstrual, Unscented
HEC
Insufflator, Vaginal
HED
Douche Apparatus, Vaginal, Therapeutic
HEE
Set, Anesthesia, Paracervical
HEG
Set, Anesthesia, Pudendal
HEH
Chamber, Decompression, Abdominal
HFY
Band, Tubal Occlusion
HGB
Clip, Tubal Occlusion
HGF
Source, Abortion Unit, Vacuum
HGG
Controller, Abortion Unit, Vacuum
HGH
Cannula, Suction, Uterine
HGX
Pump, Breast, Powered
HGY
Pump, Breast, Non-Powered
HGZ
Heater, Perineal, Direct Contact
HHA
Heater, Perineal, Radiant, Non-Contact
HHD
Pad, Menstrual, Unscented
HHE
Cup, Menstrual
HHI
System, Abortion, Vacuum
HHL
Pad, Menstrual, Scented
HHQ
System, Abortion, Metreurynter-Balloon
HHS
Transcervical Contraceptive Tubal Occlusion Device
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
HIL
Tampon, Menstrual, Scented, Deodorized
HIS
Condom
KND
Heater, Perineal
KNE
Set, Anesthesia, Obstetric
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
KXQ
Vibrator For Therapeutic Use, Genital
LTZ
Condom With Nonoxynol-9
LZL
Micro-Condom
MBU
Single-Use Internal Condom
MFD
Cannula, Intrauterine Insemination
NUR
Pad, Interlabial
MOL
Condom, Synthetic
MSC
Barrier, Std, Oral Sex
NBV
Device, Engorgement, Clitoral
NRC
Pads, Menstrual, Scented-Deodorized
NUC
Lubricant, Personal
NUQ
Pad, Menstrual, Reusable
OBB
Kit, Conception-Assist, Home Use
OBY
Condom, Female, Animal Tissue
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
OHH
Breast Pump Kit
OKW
Seminal Fluid Collection Kit
OOA
Hemorrhoid Prevention Pressure Wedge
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
K
12
2459
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
K
12
1612
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
K
11
2842
AMS ELEVATE PC
K
10
3426
LITE PELVIC FLOOR REPAIR KITS
K
11
2386
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
K
10
2815
SURELIFT PROLAPSE SYSTEM
K
11
1118
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K
09
2207
RESTORELLE POLYPROPYLENE MESH
K
09
1131
PELVIC FLOOR REPAIR SYSTEM
K
08
3499
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K
09
0713
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
K
08
3722
ASCEND
K
08
3839
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K
08
2677
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K
08
2387
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
K
08
2730
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
K
08
1710
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
K
08
2571
AVAULTA SUPPORT SYSTEM
K
08
1048
PINNACLE PELVIC FLOOR REPAIR KIT II
K
07
1512
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
K
08
0185
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
K
07
2951
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
K
07
1957
PINNACLE PELVIC FLOOR REPAIR KITS
K
06
3712
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K
06
3562
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K
05
3414
MENTOR NOVASILK MESH
K
05
1503
UGYTEX SUAL KNIT MESH
K
04
0623
AMS PERIGEE SYSTEM
K
04
0537
AMS APOGEE VAULT SUSPENSION SYSTEM
K
04
0521
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K
03
3636
AMS LARGE PORE POLYPROPYLENE MESH
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
PVT
Maternity Kit
PVU
Obstetrical Anesthesia Kit
PVV
Paracervical Anesthesia Kit
PVW
Pudendal Anesthesia Kit
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
QPD
Personal Lubricant Ring
Physical Medicine Prosthetic Devices
Prosthetic Devices
Therapeutic Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
obstetrical-and-gynecological-therapeutic-devices
/
OTP
/
K082571
View Source
AVAULTA SUPPORT SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082571
510(k) Type
Special
Applicant
C.R. BARD, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/30/2008
Days to Decision
25 days
Submission Type
Summary