FDA.reportPublic FDA data

Hobbs Medical Polypectomy Snare

Primary DI
M84972020
Brand
Hobbs Medical Polypectomy Snare
Company
HOBBS MEDICAL, INC.
Model
7202
Catalog number
7202
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.
Published
2016-09-21
Public version status
Update
Distribution status
Not 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
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844074000HOBBS MEDICAL POLYPECTOMY SNAREHobbs Medical, Inc.1985-01-03OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M84972021PackageHIBCC5Not in Commercial Distribution
M84972020PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
8606845875customerservice@hobbsmedical.com

Regulatory Flags#

DUNS number
076769355
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
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M84921890CleanCapture Aspiration Catheter218921892026-01-14
M84921891CleanCapture Aspiration Catheter218921892026-01-14
M84960050Hobbs Biliary Amsterdam Stent Kit600560052016-09-21
M84960060Hobbs Biliary Amsterdam Stent Kit600660062016-09-21
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M84960140Hobbs Biliary Amsterdam Stent Kit601460142016-09-21
M84960150Hobbs Biliary Amsterdam Stent Kit601560152016-09-21
M84963100Freeman Pancreatic Flexi-Stent Kit631063102016-09-21
M84963110Freeman Pancreatic Flexi-Stent Kit631163112016-09-21
M84963200Freeman Pancreatic Flexi-Stent Kit632063202016-09-21
M84963210Freeman Pancreatic Flexi-Stent Kit632163212016-09-21
M84965010Freeman Pancreatic Flexi-Stent Kit650165012016-09-21
M84965020Freeman Pancreatic Flexi-Stent Kit650265022016-09-21
M84965030Freeman Pancreatic Flexi-Stent Kit650365032016-09-21
M84965040Freeman Pancreatic Flexi-Stent Kit650465042016-09-21
M84965050Freeman Pancreatic Flexi-Stent Kit650565052016-09-21
M84965060Freeman Pancreatic Flexi-Stent Kit650665062016-09-21

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