remOVE DC Cutter Set

Primary DI: 04260206310921
Brand: remOVE DC Cutter Set
Company: Ovesco Endoscopy AG
Model: 14
Catalog number: 400.02.02s
Device description: The remOVE DC Cutter Set 14 is part of the remOVE System and consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes remOVE SecureCap 14 is an elastic and transparent retrieval cap for safe extraction of the clip fragments remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract
Published: 2018-01-15
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Contact Domains#

Code, Name table
Code	Name
QAG	Endoscopic Electrosurgical Clip Cutting System

Code, Device, Specialty table
Code	Device	Specialty	Class
QAG	Endoscopic Electrosurgical Clip Cutting System	Obstetrics/Gynecology	2

Submission, Supplement table
Submission	Supplement
DEN160014	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
DEN160014	000	remOVE System	Ovesco Endoscopy AG	2017-12-22	QAG

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
04260206310921	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
04260206310921	04260206310921	4260206310921

Term, Definition table
Term	Definition
Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Method table
Method

Phone, Email table
Phone	Email
+49707196528160	service@ovesco.com
+19196519449	customerservice@ovesco-usa.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
04260206311966	BougieCap P	P	400.40	2026-01-16
04260206311911	AWCduo	124 cm	200.57.05	2025-06-05
04260206311935	AWCduo	184 cm	200.57.06	2025-06-05
04260206310983	BARS Set	BARS Set	100.60	2024-11-29
04260206310648	Traction Polypectomy Snare	220 cm	200.55.10	2016-09-16
04260206311010	colonic FTRD Set	14	200.70	2018-05-28
04260206311027	Coag Dissector	165 cm	200.50	2018-07-05
04260206311034	AqaNife	1.5 mm	200.53.01	2018-10-02
04260206311041	AqaNife	2.0 mm	200.53.02	2018-10-02
04260206311058	AqaNife	2.5 mm	200.53.03	2018-10-02
04260206311065	AqaNife	3.0 mm	200.53.04	2018-10-02
04260206311072	diagnostic FTRD Set	13	200.76	2018-10-02
04260206311003	LiftUp	LiftUp	200.56.01	2022-08-22
04260206311355	LiftUp Kit	LiftUp Kit	200.56.02	2022-08-22
04260206311263	BARS Anchor silver	165 cm	200.12	2022-11-22
04260206311270	BARS Anchor black	165 cm	200.13	2022-11-22
04260206310143	OTSC Anchor	165 cm	200.10	2016-09-16
04260206310228	OTSC Twin Grasper	165 cm	200.44	2016-09-16
04260206310235	OTSC Twin Grasper	220 cm	200.45	2016-09-16
04260206310273	OTSC Proctology Anchor	38 cm	200.61	2016-09-16

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04260206310563	remOVE DC Impulse	Ovesco Endoscopy AG	QAG	2018-01-18
04260206310938	remOVE DC Cutter Set	Ovesco Endoscopy AG	QAG	2018-01-18