FDA.reportPublic FDA data

Hobbs Medical Cytology Brush

Primary DI
M84942060
Brand
Hobbs Medical Cytology Brush
Company
HOBBS MEDICAL, INC.
Model
4206
Catalog number
4206
Device description
The Hobbs Cytology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.
Published
2016-09-21
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
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182927000Pulmonary Cytology BrushHobbs Medical, Inc.2020-02-07BTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M84942062PackageHIBCC10In Commercial Distribution
M84942060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic cytology brush, single-useA device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.

Sterilization Methods#

Method table
Method

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
Primary DIBrandModelCatalogPublished
M84921890CleanCapture Aspiration Catheter218921892026-01-14
M84921891CleanCapture Aspiration Catheter218921892026-01-14
M84960050Hobbs Biliary Amsterdam Stent Kit600560052016-09-21
M84960060Hobbs Biliary Amsterdam Stent Kit600660062016-09-21
M84960090Hobbs Biliary Amsterdam Stent Kit600960092016-09-21
M84960110Hobbs Biliary Amsterdam Stent Kit601160112016-09-21
M84960120Hobbs Biliary Amsterdam Stent Kit601260122016-09-21
M84960130Hobbs Biliary Amsterdam Stent Kit601360132016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170466724DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466731DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466748DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170466755DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-07-04
04953170465987DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170465994DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466007DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466014DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170466021DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170465984DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170465991DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466004DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466011DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
14953170466028DISPOSABLE CYTOLOGY BRUSHOLYMPUS MEDICAL SYSTEMS CORP.BTG2025-06-20
04953170409011Single Use Guide Sheath KitOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-11-15
04953170408984Single Use Guide Sheath KitOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-11-05
04953170406171Single Use Guiding DeviceOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-09-07
14953170406178Single Use Guiding DeviceOLYMPUS MEDICAL SYSTEMS CORP.BTG2021-09-07
10884521809574superDimensionCovidien LPBTG2020-10-16
10884521809581superDimensionCovidien LPBTG2020-10-16
20884521809571superDimensionCovidien LPBTG2020-10-16
20884521809588superDimensionCovidien LPBTG2020-10-16
04953170401961Single Use Cytology Brush BC-205DOLYMPUS MEDICAL SYSTEMS CORP.BTG2019-08-19
14953170401968Single Use Cytology Brush BC-205DOLYMPUS MEDICAL SYSTEMS CORP.BTG2019-08-19
08714729746232CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746249CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746300CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
08714729746331CellebrityBOSTON SCIENTIFIC CORPORATIONBTG2016-09-24
10653405052340CONMEDConmed CorporationBTG2016-09-24
10884521200548superDimensionCovidien LPBTG2016-09-24