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510(k) Data Aggregation
K Number
K242857Device Name
ClearHemograsper
Manufacturer
Finemedix Co., Ltd.
Date Cleared
2025-05-21
(243 days)
Product Code
KGE
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Finemedix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ClearHemograsper has been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Device Description
ClearHemograsper is a monopolar endoscopic instrument intended to coagulate or to perform hemostasis using high-frequency current within the digestive tract. It can assist in endoscopic surgical procedures such as ESD (Endoscopic Submucosal Dissection). ClearHemograsper consists a Slider for opening or closing the Jaw, a Catheter Tube which is a part passing through the working channel of endoscope, a pair of Jaw for catching the bleeding site and for delivering high-frequency current, a plug for connecting with high frequency transmission equipment, and an irrigation port for removing foreign substances by injecting distilled water or saline solution. It is available in various working lengths.
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K Number
K242134Device Name
ClearCap Distal Attachment
Manufacturer
FINEMEDIX Co., Ltd.
Date Cleared
2024-08-20
(29 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FINEMEDIX Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearCap Distal Attachment has been designed to the distal end of the endoscope to facilitate endoscopic therapy.
The ClearCap Distal Attachment is intended for the following:
- · Gastrointestinal mucosal resection (endoscopic mucosal resection)
- · Keeping the suitable depth of the endoscope's view field
Device Description
The ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures.
The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter.
Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 are for upper GI tract.
It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.
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K Number
K231267Device Name
ClearTip
Manufacturer
Finemedix Co., Ltd.
Date Cleared
2023-06-30
(59 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Finemedix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clear Tip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).
Device Description
The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract) and tracheobronchial tree. The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. This device passes through a working channel of an endoscope, and the average contact time with the submucosal or external lesions of a gastrointestinal tract or a tracheobronchial tree is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.
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K Number
K202616Device Name
ClearCap Distal Attachment
Manufacturer
Finemedix Co., Ltd.
Date Cleared
2021-02-19
(163 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Finemedix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearCap Distal Attachment has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy. The ClearCap Distal Attachment is intended for the following: Gastrointestinal mucosal resection (endoscopic mucosal resection) Keeping the suitable depth of the endoscope's view field
Device Description
ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures. The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter. Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-EC0001, FM-EC0005, FM-EC0006 and FM-EC0007 are for lower GI Tract, and FM-EC0002, EC0003 and EC0004 are for upper GI tract. It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
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K Number
K200217Device Name
ClearEndoclip
Manufacturer
Finemedix Co., Ltd.
Date Cleared
2020-10-05
(251 days)
Product Code
PKL, FHN, MND
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Finemedix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects < 3cm
- (b) Bleeding ulcers
- (c) Arteries < 2 mm
- (d) Polyps < 1.5 cm in diameter
- (e) Diverticula in the colon
- (3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
Device Description
ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is preloaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.
ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.
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K Number
K183021Device Name
ClearEndoclip
Manufacturer
Finemedix Co., Ltd.
Date Cleared
2019-06-28
(239 days)
Product Code
PKL, FHN, MND
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Finemedix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects < 3cm
- (b) Bleeding ulcers
- (c)Arteries < 2 mm
- (d)Polyps < 1.5 cm in diameter
- (e)Diverticula in the colon
- (3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
Device Description
ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is pre-loaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.
ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.
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K Number
K183289Device Name
ClearGrasp Snare
Manufacturer
Finemedix Co., Ltd.
Date Cleared
2019-03-06
(100 days)
Product Code
FDI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Finemedix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearGrasp Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
Device Description
ClearGrasp Snare is a monopolar electrosurgical instrument intended for EMR which is Endoscopic Mucosal Resection by applying high-frequency current during endoscopic electrosurgical procedures. It is used for grasping and resecting the targeted lesion within the digestive tract by opening and closing the loop. Users can choose an oval or a crescent type based on their preference and the characteristic of the lesion. The loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. There is a stiff type distinguished by the strength of loop. The device consists of a flexible Rope Wire and various size of loop, which can be extended and rotated from the flexible Catheter Tube using two handle control knobs such as Handle and Slider. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. This device passes through the working channel of endoscope, and the average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
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