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Found 4 results
510(k) Data Aggregation
K Number
K183171Device Name
ScopeSeal Duodenoscope Protective Device
Manufacturer
GI Scientific LLC
Date Cleared
2019-10-08
(326 days)
Product Code
ODB, FDT, FEI
Regulation Number
876.1500Why did this record match?
Product Code :
ODB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.
The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
Device Description
The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.
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K Number
K153698Device Name
LumenR Tissue Retractor System
Manufacturer
LumenR, LLC
Date Cleared
2016-04-19
(118 days)
Product Code
ODB, FED, GAD
Regulation Number
876.1500Why did this record match?
Product Code :
ODB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.
Device Description
The LumenR Tissue Retractor System (LRS) is an intra-luminal surgical device facilitating tissue manipulations inside the lumen.. It is a non-powered, handmanipulated device. The LumenR Tissue Retractor System includes a LumenR Instrument Guide (LIG) and LumenR Cannula Retractor (LCR). The LIG and LCR are single use devices that are provided non-sterile. LumenR Cannula Retractor (LCR) is provided in various Lengths and Diameters in order to accommodate individually variable natural body lumens. The LumenR Cannula Retractor (LCR) comprises of (1) Handle (proximal end located outside of a patient), (2) Retractor (chamber-like expandable retractor located at the device's distal end), and (3) flexible Shaft (located in between the handle and a Retractor). LumenR Instrument Guide (LIG) is an instrument guide or a hollow conduit for existing flexible endoscopic instruments, for example, tissue forceps, which helps guide the instrument towards the target tissue, but doesn't directly interact with the tissues.
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K Number
K080550Device Name
MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
Manufacturer
MINOS MEDICAL
Date Cleared
2008-06-10
(103 days)
Product Code
ODB
Regulation Number
876.1500Why did this record match?
Product Code :
ODB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.
Device Description
The Megachannel Endoscopic Overtube is a disposable flexible PVC tube that is to be used with an endoscope. The overtube includes a proximal handle with insufflation sealing cap that accommodates a standard 12.8 mm diameter colonoscope. A removable introducer plug is attached to the distal tip to facilitate the introduction of the overtube through the gastrointestinal tract.
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K Number
K060475Device Name
EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORPORATION
Date Cleared
2006-03-17
(22 days)
Product Code
ODB, EOQ, ITX
Regulation Number
876.1500Why did this record match?
Product Code :
ODB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
Device Description
Not Found
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