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510(k) Data Aggregation
K Number
K001233Device Name
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
Manufacturer
Date Cleared
2000-12-13
(240 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
R-GROUP INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001599Device Name
ACTI-FLEX IV ADMINISTRATION SET
Manufacturer
Date Cleared
2000-09-18
(117 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
R-GROUP INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993777Device Name
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
Manufacturer
Date Cleared
2000-05-25
(199 days)
Product Code
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
R-GROUP INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The loop electrodes are designed for the LEEP or LLETZ procedure, which is performed to remove a lesion of abnormal cells from the cervix. The loop electrode is attached to an electrosurgical generator that mits an electrical current used to cut away the affected tiscues following the removal of the cells in the affected area the ball electrode is used to seal the area and stop any bleeding that may have occurred.
Some indications for use are:
- a. Cervical conizations
- b. Large Loop Excision of the Transformation Zone (LLETZ) in the Diagnosis and Treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
- c. External Anogenital Lesions
- d. Large Vaginal Intraepithelial Neoplasic (VAIN) Lesions.
Device Description
Disposable Ball and Loop Electrodes
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