FDA.reportPublic FDA data

Traction Polypectomy Snare

Primary DI
04260206310648
Brand
Traction Polypectomy Snare
Company
Ovesco Endoscopy AG
Model
220 cm
Catalog number
200.55.10
Device description
Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for endoscopic procedures such as polypectomy, endoscopic mucosa resection (EMR) or similar techniques • specific design - attached teeth to the distal part of the loop - reduces slipping of the snare upon closure • excellent maneuverability and repositioning properties • monopolar high-frequency instrument
Published
2016-09-16
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#

Product Codes#

Code, Name table
CodeName
FDISnare, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140923000TRACTION POLYPECTOMY SNAREOvesco Endoscopy AG2014-11-18FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4260206310549PackageGS110In Commercial Distribution
04260206310648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4260206310549042602063105494260206310549
04260206310648042602063106484260206310648

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
344007369
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260206311966BougieCap PP400.402026-01-16
04260206311911AWCduo124 cm200.57.052025-06-05
04260206311935AWCduo184 cm200.57.062025-06-05
04260206310983BARS SetBARS Set100.602024-11-29
04260206311010colonic FTRD Set14200.702018-05-28
04260206311027Coag Dissector165 cm200.502018-07-05
04260206311034AqaNife1.5 mm200.53.012018-10-02
04260206311041AqaNife2.0 mm200.53.022018-10-02
04260206311058AqaNife2.5 mm200.53.032018-10-02
04260206311065AqaNife3.0 mm200.53.042018-10-02
04260206311072diagnostic FTRD Set13200.762018-10-02
04260206311003LiftUpLiftUp200.56.012022-08-22
04260206311355LiftUp KitLiftUp Kit200.56.022022-08-22
04260206311263BARS Anchor silver165 cm200.122022-11-22
04260206311270BARS Anchor black165 cm200.132022-11-22
04260206310143OTSC Anchor165 cm200.102016-09-16
04260206310228OTSC Twin Grasper165 cm200.442016-09-16
04260206310235OTSC Twin Grasper220 cm200.452016-09-16
04260206310273OTSC Proctology Anchor38 cm200.612016-09-16
04260206310297OTSC Anchor 220tt220 cm200.112016-09-16

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