Search Results
Found 12 results
510(k) Data Aggregation
K Number
K173351Device Name
Panpac Flexi Shelf Pessary
Manufacturer
Panpac Medical Corporation
Date Cleared
2018-10-31
(371 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi Shelf Pessary is indicated for use as a removable structure placed in the support of a second to third degree prolapse or procidentia.
Device Description
Not Found
Ask a Question
K Number
K161106Device Name
PANPAC DISPOSABLE VACUUM CURETTES
Manufacturer
PANPAC MEDICAL CORPORATION
Date Cleared
2017-01-13
(269 days)
Product Code
HGH
Regulation Number
884.5070Why did this record match?
Applicant Name (Manufacturer) :
PANPAC MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For transcervical aspiration of the uterine cavity.
Device Description
Not Found
Ask a Question
K Number
K153422Device Name
Panpac Disposable Pessary Fitting Set
Manufacturer
Panpac Medical Corporation
Date Cleared
2016-07-14
(232 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.
Device Description
Not Found
Ask a Question
K Number
K132670Device Name
PANPAC INFLATABLE DOCUT PESSARY
Manufacturer
Panpac Medical Corporation
Date Cleared
2014-06-04
(281 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K130087Device Name
PANPAC WORD/BARTHOLIN CATHETER
Manufacturer
Panpac Medical Corporation
Date Cleared
2014-01-10
(361 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Panpac Word/ Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.
Device Description
Not Found
Ask a Question
K Number
K130273Device Name
PANPAC VAGINAL DILATORS
Manufacturer
Panpac Medical Corporation
Date Cleared
2013-08-08
(185 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.
Device Description
Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.
Ask a Question
K Number
K102898Device Name
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
Manufacturer
Panpac Medical Corporation
Date Cleared
2011-12-15
(441 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) is used to access the uterine cavity for saline infusion sonohysterography procedure.
The Bellota Sonohysterography Catheter without Cervical Cone (Model: UIC 5F) is used to access the uterine cavity for saline infusion sonohysterography procedure.
Device Description
Not Found
Ask a Question
K Number
K092982Device Name
THE PANPAC SUCTION CURETTE
Manufacturer
Panpac Medical Corporation
Date Cleared
2010-07-26
(301 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
Device Description
An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction.
Ask a Question
K Number
K092981Device Name
PANPAC VAGINAL PESSARY
Manufacturer
Panpac Medical Corporation
Date Cleared
2010-07-22
(297 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele as well as stress urinary incontinence in women.
Device Description
Not Found
Ask a Question
K Number
K092983Device Name
PANPAC HSG CATHETER SET
Manufacturer
Panpac Medical Corporation
Date Cleared
2010-06-07
(252 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Panpac Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 2