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Found 8 results
510(k) Data Aggregation
K Number
K013695Device Name
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
2002-01-08
(62 days)
Product Code
GCJ, FZP
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures
Device Description
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.
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K Number
K982984Device Name
ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1998-10-21
(56 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.
Device Description
The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.
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K Number
K981389Device Name
DISPOSABLE RE-NEW FORCEPS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1998-05-29
(43 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.
Device Description
The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures. The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.
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K Number
K981188Device Name
ELECTROSURGICAL CAUTERY PROBES
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1998-05-20
(48 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
Device Description
The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
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K Number
K980758Device Name
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1998-03-27
(28 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.
Device Description
The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.
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K Number
K974066Device Name
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1998-01-22
(87 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
Device Description
The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.
The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:
- · Grasper,
- · Fenestreded Forceps.
- · "Dolphin Nose" Dissector,
- · "Babcock", and
- · "Maryland" Dissector
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K Number
K970826Device Name
SELECTA-TIP LAPAROSCOPIC SCISSORS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1997-03-28
(22 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
Device Description
The Selecta-Tip" Laparoscopic Scissors are surgical blades used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of reusable tips. The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include: Metzenbaum, Mini, Hook, Endocut, and Micro.
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K Number
K962119Device Name
RE-NEW LAPAROSCOPIC INSTRUMENTS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1996-08-09
(70 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MICROLINE PENTAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
Device Description
The Re-New" Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include : disposable tips, and reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: Metzenbaum, Mini, Hook, Endocut, and, Micro.
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