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510(k) Data Aggregation
K Number
K242586Device Name
ArgoCap (200.52)
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2025-05-22
(265 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Ovesco Endoscopy AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ArgoCap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.
The ArgoCap is intended for the following:
- Gastrointestinal endoscopic mucosal resection and coagulation
- Keeping the suitable depth of the endoscope's view field
Device Description
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K Number
K241858Device Name
BARS Set (100.60)
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2024-08-26
(60 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Ovesco Endoscopy AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of:
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Arteries < 2 mm
- Treatment of luminal perforations (< 20 mm) and / or anastomoses (< 50 mm)
- Lumen reduction
NOTE: The BARS Set is not indicated for stent fixation, For stent fixation, use the stentfix OTSC System Set.
Device Description
The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The over-the-scope clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments are provided in the BARS Set to facilitate insertion and for mobilization of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a thread mechanism. Contents of the BARS Set are: - BARS (readily assembled unit of memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, and guide elements)
- Endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire)
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K Number
K221385Device Name
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2022-08-11
(90 days)
Product Code
PLL
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Ovesco Endoscopy AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The gel is an injection agent for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD).
Device Description
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K Number
K200684Device Name
gastroduodenal FTRD Set
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2020-06-02
(78 days)
Product Code
PKL, FDI, KNS
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Ovesco Endoscopy AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.
The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis.
For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter.
Device Description
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K Number
K183309Device Name
stentfix OTSC System Set
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2019-10-22
(327 days)
Product Code
PKL, OCZ
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Ovesco Endoscopy AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Instrument for flexible endoscopy for fixation of metal stents in the gastrointestinal tract for use in adults only.
Device Description
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K Number
DEN160014Device Name
remOVE System
Manufacturer
OVESCO ENDOSCOPY AG
Date Cleared
2017-12-22
(620 days)
Product Code
QAG
Regulation Number
876.4310Why did this record match?
Applicant Name (Manufacturer) :
OVESCO ENDOSCOPY AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The remOVE System consists of the DC Impulse and the DC Cutter Set.
The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC® (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD® (endoscopic device for full-thickness resection of colorectal wall lesions) clips made by Ovesco Endoscopy AG for the digestive tract.
The remOVE DC Cutter Set is a set of instruments for use in flexible endoscopy. It consists of a bipolar DC instrument for the fragmentation of OTSC (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD (endoscopic device for full-thickness resection of colorectal wall lesion) clips from Ovesco Endoscopy AG, a pair of forceps and a cap for removal of these fragmented clips,
Device Description
The remOVE System is comprised of the DC Impulse generator and the DC Cutter Set for the fragmentation and removal of OTSC ("over the scope clip" cleared under K101428) and FTRD ("full thickness resection device" cleared under K153550) clips from the digestive tract.
DC Impulse:
The DC Impulse is an electrical generator that produces pulsed, direct current (DC) to cut OTSC and FTRD clips. The DC Impulse generator is equipped with internal energy storage, allowing the device to generate pulsed DC without additional load on the power supply. The internal energy storage is charged before delivering the pulsed DC. DC Impulse is designed specifically for use with the DC Cutter and cannot be used with other instruments. Components required for operating the DC Impulse generator are a foot switch, a DC cord for connection to the DC Cutter instrument, and a power cord. The DC Impulse and accessories are reusable.
DC Cutter Set:
The DC Cutter Set includes three components: DC Cutter instrument, SecureCap retrieval cap, and Grasper. The DC Cutter is a bipolar, direct current instrument for flexible endoscopy and is meant for use only with the DC Impulse generator and flexible endoscopes with a working channel diameter of 2.8 mm. It is connected to the DC Impulse generator via the DC cord. The Grasper is used to retrieve the clip fragments. The dimensions of the Grasper are 2200 mm in length and 2.3 mm in diameter. The set is provided sterile and intended for single use only.
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K Number
K170867Device Name
FTRD System Set
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2017-07-25
(124 days)
Product Code
PKL, FDI, KNS, OCZ
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
Ovesco Endoscopy AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FTRD System: Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum. The FTRD System is indicated for the resection of lesions < 3 cm in the colon and rectum. Resection sizes may be less than 3 cm due to targeted tissue thickness and degree of fibrosis.
FTRD Marking Probe: Instrument for marking tissue using superficial HF coagulation in flexible endoscopy.
FTRD Grasper: Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the FTRD System.
Device Description
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K Number
K153550Device Name
FTRD System Set
Manufacturer
OVESCO ENDOSCOPY AG
Date Cleared
2016-10-12
(306 days)
Product Code
PKL, FDI, KNS, OCZ
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
OVESCO ENDOSCOPY AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DTC Snare:
The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.
- Endoscopic marking
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Bleeding ulcers
- Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon
- Closure of GI tract luminal perforations < 20 mm that can be treated conservatively
The snare is an instrument for flexible endoscopy for grasping tissue in the gastrointestinal tract.
Marking Probe:
Instrument for marking tissue using superficial HF coagulation in flexible endoscopy.
Grasper:
Instrument for flexible endoscopy for grasping and manipulation of tissue in the gastrointestinal tract, e.g. during interventions with the DTC Snare.
Device Description
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K Number
K150067Device Name
OTSC Proctology
Manufacturer
OVESCO ENDOSCOPY AG
Date Cleared
2015-09-16
(246 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
OVESCO ENDOSCOPY AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTSC Proctology instrument is indicated for compression of tissue in the anal and rectum, for treating wall lesions or for haemostasis other than hemorrhoids in proctology.
The OTSC Proctology clip is indicated for placement within the anal and rectum for the purpose of treating mucosal/submucosal defects < 3 cm.
Device Description
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K Number
K141790Device Name
AQANIFE
Manufacturer
OVESCO ENDOSCOPY AG
Date Cleared
2015-03-06
(247 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
OVESCO ENDOSCOPY AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Instrument for flexible endoscopy for dissection of tissue e.g. in endoscopic submucosal dissection (ESD) and for haemostasis during this procedure.
Device Description
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