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510(k) Data Aggregation
K Number
K061306Device Name
CO-1000 COLPOSCOPE, MULTIPLE
Manufacturer
GYNEX CORP.
Date Cleared
2006-08-07
(89 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
GYNEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gynex brand Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix.
Device Description
The CO-1000 Colposcope is a precise optical instrument designed specially for the gynecologic examination. The Gynex brand colposcope can be used to view vaginal and cervical tissues using stereoscopic optics. The Gynex CO-1000 Colposcope has detailed features that include wide field of view, long focal length, uniform illumination, adjustable brightness, ease of operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece magnification: 12.5X. Overall Magnification: 9X Focal length: 320mm. Individually adjustable evepieces. Smooth adjustable controls for fine focus. Universal Teflon ball joint gives you 360° easy motion for gross focus. Built-in green filter for enhanced contrast. Built-in rheostat. Easy replacement of halogen light bulb. Unit is completely assembled and ready for use once power is on.
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K Number
K982739Device Name
GYNEX ELECTRODES
Manufacturer
GYNEX CORP.
Date Cleared
1999-03-12
(218 days)
Product Code
HGI
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
GYNEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Soft tissue cutting & coagulation
Intraepithelial neoplasia
Condylomata acuminata
Misc. Iesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.
Device Description
The Gynex Electrodes are made of thin 0.18mm hard tungsten wire with a high melting temperature and excellent conductiveness of electric current. The electrodes are available in three different styles intended for use in two different types of electrosurgical procedure. The three styles are curved wire loop electrodes, square wire loop electrodes and ball-type electrodes. The two intended uses are excisional procedures (wire loop) and fulguration or coagulation procedures (ball electrode).
All electrode styles consist of an insulated conductive metallic shaft of varing length terminating in a bare metalic "ball" a "square wire loop" or a "curved wire loop". The wire loop electrodes vary in both width and depth of the loop. Electrode shaft diameter is constant at 2,5mm.
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K Number
K980238Device Name
GYNEX EXTENDED REACH NEEDLE
Manufacturer
GYNEX CORP.
Date Cleared
1998-08-21
(210 days)
Product Code
HEE, 85H
Regulation Number
884.5100Why did this record match?
Applicant Name (Manufacturer) :
GYNEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.
Device Description
The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.
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K Number
K980237Device Name
GYNEX ENDOSPECULUM
Manufacturer
GYNEX CORP.
Date Cleared
1998-04-08
(75 days)
Product Code
KNA, 85H
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
GYNEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.
Device Description
The Gynex Endospeculums are made of 300 series instrument grade stainless steel. There are two styles, plain handle and ratchet handle. Both have "gold" plate handles. Tip sizes are 3mm and 4mm for both handle types. Overall length of both types is 270mm (approx. 10 in.). The device is essentially identical to the Kogan endospeculum listed above. The blade tips are spring closed and pressing the handles together opens spreads the tips to compress the cervical wall and expand the cervical os or urethra for inspection.
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K Number
K980247Device Name
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
Manufacturer
GYNEX CORP.
Date Cleared
1998-03-17
(53 days)
Product Code
HDC, 85H
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
GYNEX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Snare, grasp, hold & manipulate cervical and intravaginal tissue
Device Description
The Gynex Iris and Angle Hooks & Emmett Tenaculums are made of 302 instrument grade stainless steel. All are used in similar way, each being a hook-like device used to snare, grasp, hold and manipulate the cervix, fundus and adjacent soft tissue. The important difference between the styles is that the radius of the hook tip is much smaller in the "Iris" and "angle" hook types. The devices are slender tapered metal rods, knurled on the proximal end and formed into a fine arc (hook) on the distal or working end. The devices are used to snare, hold and manipulate cervical and intravaginal tissue. Overall length of the hook/tenaculums is approximately 250mm for each type. The diameter of the hook tips is approximately 3mm for the Iris/angle styles and 8mm for the Emmett tenaculum style hook.
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