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Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
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—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
HDX
Dilator, Vaginal
2
Product Code
HFJ
Prosthesis, Fallopian Tube
2
Product Code
HFK
Mold, Vaginal
2
Product Code
HFL
Drain, Cervical
2
Product Code
HHW
Pessary, Vaginal
2
Product Code
K
23
2677
Reia pessary
2
Cleared 510(K)
K
23
2525
Yoni.Fit Bladder Support
2
Cleared 510(K)
K
23
3548
Uresta®
2
Cleared 510(K)
K
23
1786
Gynethotics™ Pessary
2
Cleared 510(K)
K
19
0277
ProVate Vaginal Support
2
Cleared 510(K)
K
18
3468
Revive Reusable Bladder Support
2
Cleared 510(K)
K
17
3351
Panpac Flexi Shelf Pessary
2
Cleared 510(K)
K
15
3422
Panpac Disposable Pessary Fitting Set
2
Cleared 510(K)
K
15
1413
Always/Tampax bladder supports
2
Cleared 510(K)
K
13
2313
PESSARY
2
Cleared 510(K)
K
13
2670
PANPAC INFLATABLE DOCUT PESSARY
2
Cleared 510(K)
K
13
1198
TIPI OTC
2
Cleared 510(K)
K
09
2981
PANPAC VAGINAL PESSARY
2
Cleared 510(K)
K
08
3769
MODIFICATION TO URESTA PESSARY
2
Cleared 510(K)
K
08
1385
URESTA PESSARY
2
Cleared 510(K)
K
06
0526
TIPI
2
Cleared 510(K)
K
03
2644
KOLPEXIN SPHERE
2
Cleared 510(K)
K
03
1463
MARINA MEDICAL SILICONE PESSARY
2
Cleared 510(K)
K
02
0512
MTI ST#1 SILICONE PESSARY
2
Cleared 510(K)
K
01
2277
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
2
Cleared 510(K)
K
01
3289
BIOTEQUE VAGINAL PESSARIES
2
Cleared 510(K)
K
00
2329
PELVX GELLHORN VAGINAL PESSARY 603-608
2
Cleared 510(K)
K
99
3308
MENTOR EVACARE VAGINAL PESSARIES
2
Cleared 510(K)
K
99
0593
PELVX INCONTINENCE DISH, MODEL 301-306
2
Cleared 510(K)
K
97
4116
PELVX INCONTINENCE RING
2
Cleared 510(K)
K
97
4117
PELVX DONUT, PELVX CUBE
2
Cleared 510(K)
K
97
4115
PELVX RING, PELVX RING WITH SUPPORT
2
Cleared 510(K)
K
96
5040
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
2
Cleared 510(K)
K
93
3654
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
2
Cleared 510(K)
K
93
0618
VAGINAL CONTINENCE DEVICE
2
Cleared 510(K)
K
92
0747
PESSARY FLEXIBLE SILICONE DONUT RING
2
Cleared 510(K)
K
92
0187
FLEXIBLE SILICONE GELIHORN
2
Cleared 510(K)
K
90
4774
INGLAT-O-BALL
2
Cleared 510(K)
K
90
4026
INFLAT-O-BALL
2
Cleared 510(K)
K
89
0565
GELLHORN PESSARY 33410 VARIOUS SIZES
2
Cleared 510(K)
K
88
3721
FEMALE CONTINENCE DEVICE
2
Cleared 510(K)
K
78
1863
DEVICE, FEMALE INCONTINENCE
2
Cleared 510(K)
K
77
1548
SILASTIC BRAND INTRAVAGINAL TARSETTE
2
Cleared 510(K)
KXP
Stent, Vaginal
2
Product Code
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction 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 20 December 2024 at 11:05 pm
OB
/
subpart-d—obstetrical-and-gynecological-prosthetic-devices
/
HHW
/
K092981
View Source
PANPAC VAGINAL PESSARY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K092981
510(k) Type
Traditional
Applicant
Panpac Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
7/22/2010
Days to Decision
297 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
HDX
Dilator, Vaginal
HFJ
Prosthesis, Fallopian Tube
HFK
Mold, Vaginal
HFL
Drain, Cervical
HHW
Pessary, Vaginal
K
23
2677
Reia pessary
K
23
2525
Yoni.Fit Bladder Support
K
23
3548
Uresta®
K
23
1786
Gynethotics™ Pessary
K
19
0277
ProVate Vaginal Support
K
18
3468
Revive Reusable Bladder Support
K
17
3351
Panpac Flexi Shelf Pessary
K
15
3422
Panpac Disposable Pessary Fitting Set
K
15
1413
Always/Tampax bladder supports
K
13
2313
PESSARY
K
13
2670
PANPAC INFLATABLE DOCUT PESSARY
K
13
1198
TIPI OTC
K
09
2981
PANPAC VAGINAL PESSARY
K
08
3769
MODIFICATION TO URESTA PESSARY
K
08
1385
URESTA PESSARY
K
06
0526
TIPI
K
03
2644
KOLPEXIN SPHERE
K
03
1463
MARINA MEDICAL SILICONE PESSARY
K
02
0512
MTI ST#1 SILICONE PESSARY
K
01
2277
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
K
01
3289
BIOTEQUE VAGINAL PESSARIES
K
00
2329
PELVX GELLHORN VAGINAL PESSARY 603-608
K
99
3308
MENTOR EVACARE VAGINAL PESSARIES
K
99
0593
PELVX INCONTINENCE DISH, MODEL 301-306
K
97
4116
PELVX INCONTINENCE RING
K
97
4117
PELVX DONUT, PELVX CUBE
K
97
4115
PELVX RING, PELVX RING WITH SUPPORT
K
96
5040
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
K
93
3654
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K
93
0618
VAGINAL CONTINENCE DEVICE
K
92
0747
PESSARY FLEXIBLE SILICONE DONUT RING
K
92
0187
FLEXIBLE SILICONE GELIHORN
K
90
4774
INGLAT-O-BALL
K
90
4026
INFLAT-O-BALL
K
89
0565
GELLHORN PESSARY 33410 VARIOUS SIZES
K
88
3721
FEMALE CONTINENCE DEVICE
K
78
1863
DEVICE, FEMALE INCONTINENCE
K
77
1548
SILASTIC BRAND INTRAVAGINAL TARSETTE
KXP
Stent, Vaginal
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-d—obstetrical-and-gynecological-prosthetic-devices
/
HHW
/
K092981
View Source
PANPAC VAGINAL PESSARY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K092981
510(k) Type
Traditional
Applicant
Panpac Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
7/22/2010
Days to Decision
297 days
Submission Type
Statement