ESD AqaNife

Basic Information

• Brand Name: ESD AqaNife
• Primary DI: 04260206310396
• Version / Model: 2.0 mm
• Catalog Number: 200.53.02
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: f7d601d3-a0ee-4ffb-b967-23b8ff1e2fbd
• Distribution End Date: 2018-11-26

Device Description

The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection • for thin tissue (needle length of 2.0 mm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260206310396	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141790	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			working channel diameter 2.8 mm
Device Size Text, specify			needle length 2.0 mm
Device Size Text, specify			working length 220 cm