Search Results
Found 3 results
510(k) Data Aggregation
K Number
K083788Device Name
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
Manufacturer
ENDO OPTIKS, INC.
Date Cleared
2009-03-03
(74 days)
Product Code
EYB
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ENDO OPTIKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.
The indications for use of the catheter are in urological applications.
Device Description
The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures.
The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.
Ask a Question
K Number
K042918Device Name
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
Manufacturer
ENDO OPTIKS, INC.
Date Cleared
2004-11-22
(31 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ENDO OPTIKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ophthalmic laser endoscope is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, visualization of the internal ocular structures in retinal detachment, and for visualization of the anterior segment which do not allow a posterior view.
Glaucoma
This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or other cyclodestructive procedures.
The endophotocoagulation of ciliary processes under direct endoscopic view is a recognized procedure and has been demonstrated to be effective in the treatment of glaucoma.
Vitreoretinal Surgery
The endoscopically controlled endophotocoagulation that is possible with the MicroProbe is also useful for endophotocoagulation:
- To produce chorioretinal scar around retinal breaks or retinotomy sites
- To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies
- To perform intraoperative retinal photocoagulation on a scleral buckle
- To perform intraoperative photocoagulation around focal neovascularization
Device Description
The Endo Optiks E2 MicroProbe™ is the principal component in a new portable laser and endoscopy system. The complete system consists of the therapeutic laser, the endoscope, the monitor and the footswitch. This compact unit creates the opportunity to simultaneously image and photocoagulate the ciliary processes through a corneal incision. It is especially indicated for the safe and effective treatment of glaucoma in combination with cataract surgery. Important vitreo-retinal applications can be realized. It can be used for the contact and non-contact excision, hemostatis, incision and vaporization of soft tissue. The E2 MicroProbe is a modification to the packaging of the original MicroProbe.
Ask a Question
K Number
K003151Device Name
MICROPOBE SERIES OF LASERS AND ACCESSORIES
Manufacturer
ENDO OPTIKS, INC.
Date Cleared
2001-01-08
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ENDO OPTIKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1