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Found 18 results
510(k) Data Aggregation
K Number
K213223Device Name
Multi-Band Ligator
Manufacturer
Beijing ZKSK Technology Co.,Ltd
Date Cleared
2022-06-06
(250 days)
Product Code
FHN, MND
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Device Description
Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.
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K Number
K172985Device Name
Ligation Device
Manufacturer
Leo Medical Co., Ltd.
Date Cleared
2018-06-14
(260 days)
Product Code
FHN, MND
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to control bleeding following polypectomy of pedunculated polyps.
Device Description
The Ligation Device is sterile and single-use, which consists of two main components, ligation loop and delivery system. And these two components provided in different sizes to consist different specifications of ligation device.
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K Number
K150718Device Name
Wi-3 HAL-RAR System
Manufacturer
AGENCY FOR MEDICAL INNOVATIONS GMBH
Date Cleared
2015-06-12
(85 days)
Product Code
FHN, IYN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
Device Description
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.
The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (< 24 hours) with tissue. The Wi-3 Arm (made of Aluminum Alloy) and Wi-3 Fixation Nut (made of polyphenylsulfone and acetal) are surface devices having limited contact duration (< 24 hours) with skin.
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K Number
K131282Device Name
NEXUS HEMORRHOID LIGATOR
Manufacturer
INX MEDICAL
Date Cleared
2013-07-11
(66 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The inx Medical Nexus™ Hemorrhoid Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
It is for use only by trained medical personnel in hospitals, clinics, and doctors' offices.
Device Description
The inx Medical Nexus™ Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue.
The inx Medical Nexus™ Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.
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K Number
K093497Device Name
THD BANDY
Manufacturer
THD SPA
Date Cleared
2010-07-15
(245 days)
Product Code
FHN, REG
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.
Device Description
The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.
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K Number
K091519Device Name
HAEMOBAND MULTI-LIGATOR
Manufacturer
HAEMOBAND SURGICAL LTD.
Date Cleared
2009-07-28
(67 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel.
Device Description
The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands.
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K Number
K070881Device Name
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
Manufacturer
SAPI MED S.P.A
Date Cleared
2007-09-26
(180 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
Device Description
The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.
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K Number
K020824Device Name
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2002-04-12
(29 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
The Injection Speedband™ Superview Super 7 is indicated for endoscopic treatment of esophageal varices utilizing combination ligation therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.
Device Description
The Speedband Superview Super7 and Injection Speedband Superview Super7 consist of two main components; a ligating unit and a handle assembly. The ligating unit consists of a cylindrical housing with a flexible silicone endoscope adapter, and seven elastic ligating bands. Suture is threaded around each band and passes through suture slots around the perimeter of the housing. The suture enters the endoscope through the working channel of an endoscope and is secured the tripwire on the handle assembly durning set-up.
The handle assembly consists of a handle knob and plastic spool mounted on a bracket with a stem. A tripwire is attached to the spool and passes through the septum and into the stem. The stem fits into the working channel of the endoscope. The septum seals the channel so suction can be maintained. On the Injection models, the septum has a port for insertion of an injection therapy needle.
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K Number
K020526Device Name
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
Manufacturer
DON WILSON/WILSON-COOK MEDICAL, INC.
Date Cleared
2002-03-19
(28 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to ligate internal hemorrhoids.
Device Description
The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.
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K Number
K001236Device Name
RIZA BAND STRETCHER (RBS)-60000
Manufacturer
R-MED, INC.
Date Cleared
2000-07-17
(90 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Product Code :
FHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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