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510(k) Data Aggregation
K Number
K974032Device Name
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
Manufacturer
A & A MEDICAL, INC.
Date Cleared
1997-12-22
(60 days)
Product Code
HFC
Regulation Number
884.1050Why did this record match?
Product Code :
HFC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically
Device Description
The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. It is comprised of 3 components: Plunger, O-ring and external tubing. Suction is created by pulling the plunger with a handle outward. It has a small OD of 2.6mm, which minimizes pain and discomfort to the patient. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically
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K Number
K960263Device Name
CERVICAL MUCOUS ASPIRATION CATHETER
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
1996-08-29
(224 days)
Product Code
HFC
Regulation Number
884.1050Why did this record match?
Product Code :
HFC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
cervical mucous aspiration for the evaluation of infertility.
Device Description
The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility. The Cervical Mucous Aspiration Catheter will be made from TFE and nylon. TFE is widely known and accepted in the medical field, therefore, biocompatibility is assured. Biocompatibility testing has been performed on the nylon and the results show a reasonable assurance of safety and effectiveness.
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K Number
K954903Device Name
PEDI VAGINAL ASPIRATOR
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
1996-04-29
(187 days)
Product Code
HFC
Regulation Number
884.1050Why did this record match?
Product Code :
HFC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse.
Device Description
The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse. This device will be made from polyurethane and polyethylene.
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