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510(k) Data Aggregation
K Number
K042648Device Name
REPROCESSED COLD BIOPSY FORCEPS
Manufacturer
STERILMED, INC.
Date Cleared
2005-07-20
(295 days)
Product Code
NON
Regulation Number
876.1075Why did this record match?
Product Code :
NON
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope.
Device Description
The device consists of a proximal handle which is connected, via a coil, spring or rod mechanism, to the biopsy jaws at the distal tip. The biopsy forceps range from 100 to 240cm in length and 1.8-3.3mm in diameter. The jaws range from 1.8 to 3.3mm in diameter. The jaws of the forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth.
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K Number
K042659Device Name
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
Manufacturer
MEDISISS
Date Cleared
2005-02-14
(139 days)
Product Code
NON, REG
Regulation Number
876.1075Why did this record match?
Product Code :
NON
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.
Device Description
MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.
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K Number
K042594Device Name
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
Manufacturer
VANGUARD MEDICAL CONCEPTS, INC.
Date Cleared
2005-01-25
(124 days)
Product Code
NON
Regulation Number
876.1075Why did this record match?
Product Code :
NON
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GI forceps are designed for insertion through an appropriate sized endoscopy channel for removal and histological sampling of tissue. Biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract.
Device Description
Vanguard Reprocessed Non-Electric Biopsy Forceps consist of a flexible sheath with distal grasping cups controlled by a proximal control handle. When used with a compatible endoscope, GI biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract. Biopsy forceps are designed for insertion through a predetermined diameter biopsy channel. Vanguard receives previously used non-electric GI biopsy forceps from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
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