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Found 17 results
510(k) Data Aggregation
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?
Product Code :
KNA
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
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K Number
K102141Device Name
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
2011-05-06
(281 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for the treatment of abscesses and cysts of the Bartholin gland.
Device Description
The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use.
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K Number
K093904Device Name
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
Manufacturer
GLENVEIGH SURGICAL, LLC
Date Cleared
2010-04-14
(113 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
Device Description
The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.
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K Number
K082939Device Name
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
2009-09-03
(336 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.
Device Description
The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage procedure in order to prolong pregnancy to a successful delivery. The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cervical cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The Cook® Fetal Membrane Manipulator is comprised of a November polycarbonate dual lumen catheter with a silicone balloon. The balloon catheter assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.
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K Number
K062438Device Name
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
Manufacturer
COOK OB/GYN
Date Cleared
2006-10-27
(67 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Device Description
The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.
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K Number
K060289Device Name
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
Manufacturer
FRONTLINE MEDICAL
Date Cleared
2006-07-07
(151 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure.
V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.
Device Description
EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use.
V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.
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K Number
K013597Device Name
TAMPONADE UTERINE BALLOON CATHETER SET
Manufacturer
COOK OB/GYN
Date Cleared
2002-04-17
(168 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile. "Use of this device is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted."
Device Description
The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum uterine bleeding. The materials of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.
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K Number
K014248Device Name
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
Manufacturer
UROGYN LTD.
Date Cleared
2002-03-21
(85 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance.
The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of Pelvic organ prolapse/vaginal prolapse and is equivalent to the currently employed procedure, which is performed with the Deschamps™ device, distributed by BEI Medical Systems Corporation.
The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.
Device Description
The UroGyn DND 202™ device is a surgical tool, consisting of a plastic thimble connected to an operating box. The thimble element of the device contains a surgical needle and a cartridge preloaded with suture material.
The DND 202™ is mounted on the surgeon's index finger and controlled externally. DND 202™ allows the surgeon to operate guided by palpation only. The device is used to anchor the suture material to dense connective tissue at the hipbone during Bladder Neck Suspension for the treatment of Urinary Incontinence or Pelvic Organ Prolapse. The vaginal mucosa is open through surgical incision and the surgeon's finger, with the thimble of the DND 202 mounted on it, is placed through the incision to palpate the desired anatomical structure. The device is then operated externally by the other hand causing the projection of the surgical needle into the tissue. The needle reaches the opposite side of the device and retrieves the suture material from the cartridge. A reverse motion of the needle with the suture material hooked at the tip of the needle retracts the needle back into its housing. The surgeon remove his hand with the device out of the vagina, release the suture material from the needle and ends up with two ends of the suture material anchored to the target connective tissue and ready for tying.
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K Number
K001590Device Name
DND 101
Manufacturer
UROGYN LTD.
Date Cleared
2000-08-02
(77 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990738Device Name
DR. JAHANGER'S CUTTER
Manufacturer
M.S. JAHANGER, MD
Date Cleared
1999-10-29
(238 days)
Product Code
KNA
Regulation Number
884.4530Why did this record match?
Product Code :
KNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.
Device Description
Not Found
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