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Innolitics
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Review Panel
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Review Panel
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Review Panel
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Miscellaneous
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)
Show All 32 Submissions
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 16 August 2024 at 11:05 pm
GU
/
subpart-d—prosthetic-devices
/
FAE
/
K953640
View Source
DUNA II PENILE PROSTHESIS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
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
Show All 32 Submissions
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
/
K953640
View Source
DUNA II PENILE PROSTHESIS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...