Hobbs Medical Polypectomy Snare

Basic Information

• Brand Name: Hobbs Medical Polypectomy Snare
• Primary DI: M84972020
• Version / Model: 7202
• Catalog Number: 7202
• Company Name: HOBBS MEDICAL, INC.
• Labeler DUNS: 076769355
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2024-08-07
• Public Version Status: Update
• Public Device Record Key: 70cd230e-bb4a-4ea4-a084-0297a528ea93
• Distribution End Date: 2022-05-12

Device Description

A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.

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
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M84972021	HIBCC	Box	5	Not in Commercial Distribution	2022-05-12
Primary	M84972020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K844074	000