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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
FAE
Prosthesis, Penile
2
Product Code
K
18
3619
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
2
Cleared 510(K)
K
18
1673
Rigi10 Malleable Penile Prosthesis
2
Cleared 510(K)
K
09
0663
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
2
Cleared 510(K)
K
08
2006
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
2
Cleared 510(K)
K
04
0959
MENTOR GENESIS PENILE PROSTHESIS
2
Cleared 510(K)
K
96
3328
AMS AMBICOR PENILE PROSTHESIS
2
Cleared 510(K)
K
95
3640
DUNA II PENILE PROSTHESIS
2
Cleared 510(K)
K
95
1716
AMS 650 MALLERABLE PENIEL PROSTHESIS
2
Cleared 510(K)
K
92
0420
DURA II PENILE PROSTHESIS
2
Cleared 510(K)
K
91
2935
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
2
Cleared 510(K)
K
91
2344
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
2
Cleared 510(K)
K
91
0214
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
2
Cleared 510(K)
K
90
4262
MINNOW PENILE IMPLANT PROTECTOR
2
Cleared 510(K)
K
90
0371
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
2
Cleared 510(K)
K
90
1482
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
2
Cleared 510(K)
K
89
6941
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
2
Cleared 510(K)
K
89
0402
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
2
Cleared 510(K)
K
87
1653
DURAPHASE PENILE PROSTHESIS
2
Cleared 510(K)
K
86
4040
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
2
Cleared 510(K)
K
86
0517
MENTOR CORPORAL DILATORS
2
Cleared 510(K)
K
85
0019
OMNI PHASE PENILE PROSTHESIS
2
Cleared 510(K)
K
84
3280
MALLEABLE PENILE PROSTHESIS
2
Cleared 510(K)
K
83
4347
FLEXI-FLATE PENILE IMPLANT
2
Cleared 510(K)
K
83
4504
ESKA JONAS SILICON-SILVER PENILE
2
Cleared 510(K)
K
83
2043
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
2
Cleared 510(K)
K
83
1660
AMS MALLEABLE PENILE PROSTHESIS
2
Cleared 510(K)
K
83
0917
SURGITEK SIZER FOR PENILE PROSTHESIS
2
Cleared 510(K)
K
83
0048
INFLATABLE PENILE PROSTH. - CYLINDER
2
Cleared 510(K)
K
82
1628
THE INFLATABLE PENILE PROSTHESIS
2
Cleared 510(K)
K
82
0081
ESKA JONAS SILICONE-SILVER PENILE PROST
2
Cleared 510(K)
K
80
3111
ERECTAID
2
Cleared 510(K)
K
79
2724
AMS MALLEABLE OR JONAS SILICONE-SILVER
2
Cleared 510(K)
FAF
Prosthesis, Testicular
3
Product Code
FHW
Device, Impotence, Mechanical/Hydraulic
3
Product Code
FTO
Prosthesis, Testicle
3
Product Code
FTQ
Prosthesis, Penis, Rigid Rod
2
Product Code
JCW
Prosthesis, Penis, Inflatable
3
Product Code
QGA
Penile Implant Surgical Accessories
1
Product Code
ESW
Prosthesis, Esophageal
2
Product Code
MQR
Stent, Colonic, Metallic, Expandable
2
Product Code
MUM
Stent, Metallic, Expandable, Duodenal
2
Product Code
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
2
Product Code
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
2
Product Code
PAG
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
2
Product Code
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
2
Product Code
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
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
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Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
GU
/
subpart-d—prosthetic-devices
/
FAE
/
K910214
View Source
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910214
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/1991
Days to Decision
98 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
FAE
Prosthesis, Penile
K
18
3619
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
K
18
1673
Rigi10 Malleable Penile Prosthesis
K
09
0663
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K
08
2006
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K
04
0959
MENTOR GENESIS PENILE PROSTHESIS
K
96
3328
AMS AMBICOR PENILE PROSTHESIS
K
95
3640
DUNA II PENILE PROSTHESIS
K
95
1716
AMS 650 MALLERABLE PENIEL PROSTHESIS
K
92
0420
DURA II PENILE PROSTHESIS
K
91
2935
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K
91
2344
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
K
91
0214
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
K
90
4262
MINNOW PENILE IMPLANT PROTECTOR
K
90
0371
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K
90
1482
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K
89
6941
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K
89
0402
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
K
87
1653
DURAPHASE PENILE PROSTHESIS
K
86
4040
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K
86
0517
MENTOR CORPORAL DILATORS
K
85
0019
OMNI PHASE PENILE PROSTHESIS
K
84
3280
MALLEABLE PENILE PROSTHESIS
K
83
4347
FLEXI-FLATE PENILE IMPLANT
K
83
4504
ESKA JONAS SILICON-SILVER PENILE
K
83
2043
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K
83
1660
AMS MALLEABLE PENILE PROSTHESIS
K
83
0917
SURGITEK SIZER FOR PENILE PROSTHESIS
K
83
0048
INFLATABLE PENILE PROSTH. - CYLINDER
K
82
1628
THE INFLATABLE PENILE PROSTHESIS
K
82
0081
ESKA JONAS SILICONE-SILVER PENILE PROST
K
80
3111
ERECTAID
K
79
2724
AMS MALLEABLE OR JONAS SILICONE-SILVER
FAF
Prosthesis, Testicular
FHW
Device, Impotence, Mechanical/Hydraulic
FTO
Prosthesis, Testicle
FTQ
Prosthesis, Penis, Rigid Rod
JCW
Prosthesis, Penis, Inflatable
QGA
Penile Implant Surgical Accessories
ESW
Prosthesis, Esophageal
MQR
Stent, Colonic, Metallic, Expandable
MUM
Stent, Metallic, Expandable, Duodenal
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
PAG
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-d—prosthetic-devices
/
FAE
/
K910214
View Source
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910214
510(k) Type
Traditional
Applicant
AMERICAN MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/25/1991
Days to Decision
98 days