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510(k) Data Aggregation
K Number
K203586Device Name
EndoSerter-PL
Manufacturer
Date Cleared
2022-02-02
(421 days)
Product Code
Regulation Number
886.4300Why did this record match?
Product Code :
OTZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoSerter® PL is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.0 mm in diameter and 100 microns in central thickness into the anterior chamber through a minimum 4.0 mm incision during endothelial keratoplasty procedures and for loading and storage of donor transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 48 hours.
Device Description
The EndoSerter®-PL is a sterile, single use, handheld, manual ophthalmic surgical instrument. It is used to preload a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon is performed by trained technician at the eye bank.
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K Number
K121579Device Name
EK DELIVERY DEVICE
Manufacturer
Date Cleared
2012-10-03
(126 days)
Product Code
Regulation Number
886.4300Why did this record match?
Product Code :
OTZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:
- An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100 – 220 µm of thickness into the anterior chamber of the eye during endothelial keratoplasty.
- For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of ≤ 8.5 mm)
- For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.
Device Description
The Endothelial Keratoplasty Injector is a single-use, disposable device that allows an ophthalmic surgeon to insert a previously prepared disc of posterior donor cornea into the eye of a recipient patient through a small incision during a posterior comeal transplant surgical procedure. The function of the device is to insert the flat disc of donor comeal tissue within a cylindrical tube that is sized to fit into 5.1 mm or larger corneal or scleral incision, and to pull or push this donor corneal tissue into the anterior chamber of the eye as part of a Endothelial Keratoplasty procedure. This device was designed to insert donor posterior corneal tissue ≤ 8.5 mm in diameter, 100um to 220um in thickness, through a 5.1 mm or larger corneal incision.
The EK Delivery device consists of four components: (1) the Trocar which is used to hold the graft material and introduce it into the anterior chamber of the recipient eye, (2) the Trocar Holder, which is used to close the proximal end of the Trocar and as an ergonomic handle to aid the surgeon handling the device, (3) the Injector Assembly, which is a plunger to push the endothelial keratoplasty tissue out of the Trocar and into the anterior chamber of the recipient eye, and (4) End Plug used during shipping. Delivers a circular endothelial tissue button in a rolled configuration.
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K Number
K110734Device Name
NCI SPATULA
Manufacturer
Date Cleared
2012-05-31
(442 days)
Product Code
Regulation Number
886.4300Why did this record match?
Product Code :
OTZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K102999Device Name
TRIMOTION INJECTOR
Manufacturer
Date Cleared
2011-12-29
(447 days)
Product Code
Regulation Number
886.4300Why did this record match?
Product Code :
OTZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kaneka Trimotion™ Injector is indicated for insertion and placement of donor corneal tissue (diameter: ≤ 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.
Device Description
The Kaneka Trimotion™ Injector is a single-use pen-shaped injector made of stainless steel and biocompatible plastics. It is used to fold, insert, and place donor corneal tissue by means of a major surgical procedure into a human eye during the Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure. Two color-coded sliding controls, called "pushers", are used to control the delivery of the donor tissue. Irrigation with intraocular irrigating solution and an air injection are applied through the device to aid in tissue delivery and placement. The system provides a tubular pathway through an incision posterior to the cornea limbus, allowing delivery of the donor tissue into the human eye.
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K Number
K090626Device Name
ENDOSERTER
Manufacturer
Date Cleared
2011-01-21
(683 days)
Product Code
Regulation Number
886.4300Why did this record match?
Product Code :
OTZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.
Device Description
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