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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
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Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
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Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
HDX
Dilator, Vaginal
2
Product Code
K
23
3689
Hope&Her Vaginal Dilators
2
Cleared 510(K)
K
22
2492
Hope&Her Vaginal Dilators
2
Cleared 510(K)
K
23
1430
Intimate Rose Vaginal Dilators
2
Cleared 510(K)
K
22
0035
Milli Vaginal Dilator
2
Cleared 510(K)
K
21
1959
Milli Vaginal Dilator
2
Cleared 510(K)
K
13
0273
PANPAC VAGINAL DILATORS
2
Cleared 510(K)
K
07
1754
NEO-VAGINA SURGERY SET AND ACCESSORIES
2
Cleared 510(K)
K
00
3380
BIOTEQUE VAGINAL DILATOR
2
Cleared 510(K)
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
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
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Review Panel
Last synced on 16 August 2024 at 11:05 pm
OB
/
subpart-d—obstetrical-and-gynecological-prosthetic-devices
/
HDX
/
K130273
View Source
PANPAC VAGINAL DILATORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130273
510(k) Type
Traditional
Applicant
Panpac Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
8/8/2013
Days to Decision
185 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
K
23
3689
Hope&Her Vaginal Dilators
K
22
2492
Hope&Her Vaginal Dilators
K
23
1430
Intimate Rose Vaginal Dilators
K
22
0035
Milli Vaginal Dilator
K
21
1959
Milli Vaginal Dilator
K
13
0273
PANPAC VAGINAL DILATORS
K
07
1754
NEO-VAGINA SURGERY SET AND ACCESSORIES
K
00
3380
BIOTEQUE VAGINAL DILATOR
HFJ
Prosthesis, Fallopian Tube
HFK
Mold, Vaginal
HFL
Drain, Cervical
HHW
Pessary, Vaginal
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
/
HDX
/
K130273
View Source
PANPAC VAGINAL DILATORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130273
510(k) Type
Traditional
Applicant
Panpac Medical Corporation
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
8/8/2013
Days to Decision
185 days
Submission Type
Statement