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510(k) Data Aggregation
K Number
K201511Device Name
Reprocessed Endoscopic Trocars and Sleeves
Manufacturer
Stryker Sustainability Solutions
Date Cleared
2020-07-31
(56 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions.
Device Description
The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) are sterile, single patient use instruments consisting of a radiolucent sleeve (cannula) and obturators in sizes ranging from 5-12 mm in diameter. There different obturators; Bladeless, Dilating Tip (Bladed) and Blunt Tip. The bladeless obturator contains a clear, tapered optical element, and when used with an endoscope provides visibility of individual tissue layers during insertion. The Dilating Tip (Bladed) obturator has a sharp, flat-bladed tip and spring-loaded shield. The shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The Blunt Tip obturator has a blunt plastic tip which gently moves aside any viscera that may be adjacent to abdominal or thoracic wall.
The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm bladeless trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Trocars with Optiview Technology incorporates a design enhancement that reduces the incidence of trocar induced endoscope lens smudging during endoscope insertion.
The Reprocessed Sleeves are sterile, single patient use devices with a radiolucent sleeve (cannula). The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize qas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
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K Number
K182828Device Name
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
Manufacturer
Surgical Instrument Service and Savings Inc
Date Cleared
2019-04-15
(192 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
Device Description
The Medline ReNewal Reprocessed Carter-Thomason Suture Passer Set (models CTI-512N, CTI-1015N, PG-15S, and PG-5/10) is a sterile, single-case use, hand-held suture grasping device that is designed to pass suture through soft tissue.
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K Number
K172097Device Name
Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
Manufacturer
Renovo, Inc.
Date Cleared
2017-10-06
(87 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Ethicon Bladeless Trocars are intended for use in thoracic, gynecologic, laparoscopic and other abdominal or minimally invasive surgical procedures to establish a path of entry for endoscopic or minimally invasive instruments. The reprocessed optical trocar may be used with or without visualization for primary and secondary insertions.
The Reprocessed Ethicon Universal Trocar Sleeves are intended for use in thoracic, gynecologic, laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Device Description
A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the port, and; the obturator which is a mechanism that allows the cannula to penetrate the abdomen. The trocars contained in this submission are bladeless. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
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K Number
K172093Device Name
Reprocessed Covidien Trocar
Manufacturer
Renovo, Inc.
Date Cleared
2017-10-05
(86 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Covidien Trocars are indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
Device Description
A trocar is a sterile device used in a variety of endoscopic procedures to establish and maintain a port of entry for surgical tools. Trocars consists of three primary components; the cannula which allows access into the abdominal cavity during the procedure; the seal, located at the top of the cannula allows instruments to pass through the cannula while preventing loss of pneumoperitoneum when instruments are inserted and withdrawn from the obturator, which is a mechanism that allows the cannula to penetrate the abdomen. There are also various configurations of diameter and length, but all models have the same basic design, materials, and technological characteristics.
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K Number
K160740Device Name
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
Manufacturer
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
Date Cleared
2016-05-06
(50 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW Technology has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Medline ReNewal Reprocessed ENDOPATH XCEL Universal Trocar Stability Sleeve with OPTIVIEW Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Device Description
The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology devices are sterile, single-patient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments that are 5-mm in diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an integrated seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation. The trocars contain OPTIVIEW Technology that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.
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K Number
K153258Device Name
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
Manufacturer
Surgical Instrument Service and Savings (dba Medline ReNewal
Date Cleared
2016-04-05
(147 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Device Description
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.
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K Number
K133414Device Name
REPROCESSED CLOSURE SYSTEM
Manufacturer
STERILMED, INC.
Date Cleared
2014-01-22
(76 days)
Product Code
NLM, GCJ, GEJ, HCF
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reprocessed closure systems are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.
Device Description
The closure system is a set of three components; consisting of one suture passer, one 5mm guide and one 10/12mm guide. The suture passer has a stainless steel shaft with a pointed tip that opens on one side to grasp the suture and a polycarbonate handle with a ring that actuates the tip. The 5mm and 10/12mm guides are made of polycarbonate with a cylindrical head on the proximal end connected to a shaft that tapers to a tip on the distal end. Each guide has two holes in the cylindrical head that pass through to opposite sides of the shaft. The holes allow the suture passer to be passed through the guide.
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K Number
K132629Device Name
REPROCESSED DILATING TIP TROCARS
Manufacturer
STRYKER SUSTAINABILITY SOLUTIONS
Date Cleared
2013-12-31
(131 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Device Description
Reprocessed Bladeless Trocar: The Reprocessed Bladeless Trocar, is a sterile single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator contains a clear, tapered optical element. The 5 mm obturator accommodates an appropriately sized 0° endoscope and provides visibility of individual tissue layers during insertion. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Dilating Tip (Bladed) Trocar: The Reprocessed Dilating Tip Trocar is a sterile, single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator has a sharp, flat-bladed tip and spring-loaded shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Stability (Universal) Sleeve (Cannula): The Reprocessed Stability Sleeve is a sterile, single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
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K Number
K121240Device Name
REPROCESSED ENDOSCOPIC TROCARS
Manufacturer
STERILMED, INC.
Date Cleared
2012-06-11
(48 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.
Device Description
The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures.
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K Number
K111002Device Name
REPROCESSED ENDOSCOPIC TROCARS
Manufacturer
STERILMED, INC.
Date Cleared
2011-07-18
(98 days)
Product Code
NLM
Regulation Number
876.1500Why did this record match?
Product Code :
NLM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.
Device Description
The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be blunt, bladed, or shielded-bladed (blade covered by a retractable shield). Reprocessed endoscopic trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during abdominal, thoracic or gynecologic surgical procedures.
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