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Found 12 results
510(k) Data Aggregation
K Number
K223866Device Name
Carevix Suction Cervical Stabilizer
Manufacturer
Aspivix SA
Date Cleared
2023-01-25
(33 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.
Device Description
Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.
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K Number
K203820Device Name
ASPIVIX v1.1 Cervical Suction Tenaculum
Manufacturer
Aspivix S.A.
Date Cleared
2021-08-17
(231 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
Device Description
ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.
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K Number
K142204Device Name
Bioceptive Suction Cervical Retractor
Manufacturer
Bioceptive Inc.
Date Cleared
2014-12-19
(130 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bioceptive Suction Cervical Retractor is indicated to snare, grasp, hold and manipulate cervical tissue.
Device Description
Not Found
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K Number
K082349Device Name
JARIT HULKA UTERINE TENACULUM FORCEPS
Manufacturer
J. JAMNER SURGICAL INSTRUMENTS, INC.
Date Cleared
2008-11-21
(98 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.
Device Description
JARIT Hulka Uterine Tenaculum Forceps are an 11-inch long stainless steel, ring-handled instrument with ratchet closure having a single-tooth hook at the distal end of one arm and a 3.6 mm diameter uterine sound probe at the distal end of the other arm. The device is reusable, sterilizable and packaged non-sterile.
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K Number
K073182Device Name
GYN DISPOSABLES TENACULUM 356T
Manufacturer
GYN-DISPOSABLES, INC.
Date Cleared
2007-11-28
(15 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Snare, grasp, hold and manipulate cervical and intravaginal tissue.
Device Description
GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
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K Number
K062563Device Name
FEMTEN CERVICAL TENACULUM
Manufacturer
FEM SUITE, L.L.C.
Date Cleared
2007-05-18
(260 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemSuite, LLC, FemTen™ Cervical Tenaculum is a sterile, disposable, manual instrument indicated for single patient use to hold and manipulate the cervix. This device is typically used in conjunction with endometrial biopsy.
Device Description
Not Found
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K Number
K060573Device Name
BURBANK TENACULUM
Manufacturer
VASCULAR CONTROL SYSTEMS, INC
Date Cleared
2006-04-21
(46 days)
Product Code
HDC, DXC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures.
This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
Device Description
The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.
A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.
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K Number
K032585Device Name
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
Manufacturer
RON-TECH MEDICAL LTD.
Date Cleared
2004-01-09
(141 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
Device Description
The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to hold and secure the ultrasound transducer in place on a uterine tenaculum, while performing the sonographic procedure. The configuration of the device allows the physician to manipulate the ultrasound transducer with one hand, thus freeing the other hand to perform the required procedure. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System consists of a reusable uterine tenaculum with an adaptor bar, a sterile, disposable adaptor and a disposable probe connector.
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K Number
K030078Device Name
BURBANK TENACULUM, MODEL 09-0011-01
Manufacturer
VASCULAR CONTROL SYSTEMS, INC
Date Cleared
2003-01-24
(15 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.
Device Description
The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.
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K Number
K001818Device Name
UTERINE TENACLUM HOOK
Manufacturer
TOWNE BROTHERS (PVT.), LTD.
Date Cleared
2000-08-30
(76 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Product Code :
HDC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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