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Found 5 results
510(k) Data Aggregation
K Number
K090796Device Name
MULTI-BITE HOT BIOPSY FORCEPS
Manufacturer
ENDO-THERAPEUTICS, INC.
Date Cleared
2009-11-25
(246 days)
Product Code
KGE
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
ENDO-THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biopsy forceps are intended for use in collecting tissue samples for histological examination.
Device Description
Multi-bite Electric (Hot) Biopsy Forceps
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K Number
K031026Device Name
ETI BIPOLAR HEMOSTATIC PROBE
Manufacturer
ENDO-THERAPEUTICS, INC.
Date Cleared
2003-06-27
(88 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
ENDO-THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ETI Hemostatic Probe is intended for use during endoscopic procedures where electrosurgery is required to cauterize tissue of actual or potentially bleeding sites in the gastrointestinal tract. The device also can be used for irrigation.
Device Description
Not Found
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K Number
K023603Device Name
ENDO-GLIDE GUIDEWIRE
Manufacturer
ENDO-THERAPEUTICS, INC.
Date Cleared
2003-02-19
(114 days)
Product Code
OCY, GCA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ENDO-THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
Device Description
The Endo-Glide Guidewire has a range of diameters from 0.025" to 0.035" and lengths from 250cm to 450cm. The wires are offered with and without a 50mm radiopaque platinum distal tip (curved and straight). The wires are assembled with a solid nitinol or stainless steel core wire, which can be tapered at the distal tip. A lubricious coating (PTFE or hydrophilic) surrounds the entire core and/or tip, which also provides insulation.
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K Number
K012725Device Name
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
Manufacturer
ENDO-THERAPEUTICS, INC.
Date Cleared
2001-11-08
(85 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENDO-THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo-Therapeutics Laparoscopic Surgical Instruments are a line of reusable general surgical forceps, graspers and scissors intended to be used for lifting, dissecting, cutting organs and tissue during general open and laparoscopic procedures.
Device Description
Not Found
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K Number
K012977Device Name
VARICES INJECTION NEEDLE
Manufacturer
ENDO-THERAPEUTICS, INC.
Date Cleared
2001-11-02
(58 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ENDO-THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Varices Injection Needles are used for endoscopic injection of legally marked sclerotherapy agent and dyes into esophageal or colonic varices
Device Description
Not Found
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