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510(k) Data Aggregation
K Number
K213194Device Name
HD Mediastinoscope
Manufacturer
Karl Storz Endoscopy America, Inc.
Date Cleared
2022-06-23
(267 days)
Product Code
EWY
Regulation Number
874.4720Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
Device Description
The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.
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K Number
K202272Device Name
HD Mediastinoscope
Manufacturer
Karl Storz Endoscopy America, Inc.
Date Cleared
2021-05-11
(273 days)
Product Code
EWY
Regulation Number
874.4720Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
Device Description
The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
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K Number
K170757Device Name
Aegis Transit System
Manufacturer
Boston-Biomedical Associates
Date Cleared
2017-07-14
(123 days)
Product Code
EWY
Regulation Number
874.4720Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).
The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.
Device Description
The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below:
- . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171;
- The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used;
- . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171;
- . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and
- . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid.
Both devices are being used in accordance with their cleared indications for use.
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K Number
K160171Device Name
Illuminated Mediastinal Access Port
Manufacturer
Aegis Surgical Ltd
Date Cleared
2016-02-26
(30 days)
Product Code
EWY
Regulation Number
874.4720Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.
The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
Device Description
Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device provides open, illuminated surgical access to the mediastinum. The device consists of the following components: Cannula with a working channel, fiber optic bundles, ergonomic handle and blunt tip trocar.
The base of the cannula has fiber optic bundles incorporated that may be connected to a standard endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The ergonomic handle provides a secure grip and ease of maneuverability to the user. The device includes a blunt trocar for dissecting tissue planes. The trocar/cannula access device also includes a handle for connection to a support arm. The handle allows the Mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinoscope and to provide stability for the Mediastinoscope during operation.
The entire device is disposable, single use and provided pre-sterilized.
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K Number
K141622Device Name
ILLUMINATED MEDIASTINOSCOPE
Manufacturer
AEGIS SURGICAL LTD
Date Cleared
2015-01-09
(206 days)
Product Code
EWY
Regulation Number
874.4720Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.
The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
Device Description
The Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device includes a blunt trocar for dissecting tissue planes. The open cannula provides for direct visualization of the surgical space and includes small notches at the rim to anchor sutures.
The base of the cannula has fiber optic bundles incorporated that may be connected to a fiber optic light cable and an endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source.
The trocar/cannula access device also includes a handle for connection to a support arm. This allows the mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the mediastinoscope, and to provide stability for the mediastinoscope during operation.
The entire device is disposable, single use and is provided pre-sterilized.
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K Number
K111788Device Name
ENDOEYE HD II
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
2012-01-13
(203 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Device Description
The ENDOEYE HD II - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy and endoscopic surgery within the abdominal cavities, which is basically identical to the predicate devices for the same application areas.
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K Number
K102379Device Name
LTF-Y0009; MAJ-YOO41; XOEV-3D1
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORPORATION
Date Cleared
2011-01-05
(135 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LTF-Y0009 (3D Laparo-Thoraco Videoscope): This instrument has been designed for use in conjunction with light source, video system centers, 3D Video Mixer, 3D monitor, documentation equipment, hand instruments, and other ancillary equipment for endoscopy and endoscopic surgery within the peritoneal and thoracic cavity.
MAJ-Y0041 (3D Video Mixer): This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope and Video System Center for 3D video observation.
XOEV-3D1(Polarized 3D Monitor): This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope, light source, video system center and 3D Video Mixer for endoscopic diagnosis and video observation.
MAJ-Y0108 (3D glasses): This instrument has been designed to be used with Olympus 3D Laparo-Thoraco videoscope, light source, video system center, 3D Video Mixer and 3D monitor for 3D video observation.
Device Description
3D Laparo-Thoraco Videoscope (LTF-Y0009) is a video endoscope used for endoscopy and endoscopic surgery within the peritoneal and thoracic cavity. LTF-Y0009 is basically identical to predicate device 3D Laparoscope, for the same application areas. The 3D video observation of this system is implemented with following process. The captured signals from two CCDs which correspond to left and right eye incorporated in distal end of the subject LTF-Y0009 are transferred to the MAJ-Y0041 via CV-Y0001. CV-Y0001 converts the captured signals into video image signals, and transmits them to the MAJ-Y0041. The MAJ-Y0041 converts the image signals into 3D video signal and transfers it to the XOEV-3D1. On the XOEV-3D1, 3D video image is displayed as passive stereo type which has different polarizing angle in the left and right; therefore, the MAJ-Y0108 is required to obtain 3D video image. The MAJ-Y0108's glasses have polarizing films on them which correspond to their each polarizing angle and it enables 3D observation to the users.
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K Number
K090980Device Name
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
Manufacturer
OLYMPUS WINTER & IBE GMBH
Date Cleared
2009-06-29
(83 days)
Product Code
NWB, GCJ, KOG, NLM
Regulation Number
876.1500Why did this record match?
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Matched: '874.4720'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.
Device Description
The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.
The major difference from the predicate device is only the NBI function added to the subject device.
When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.
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