FDA.reportPublic FDA data

Endoch

Primary DI
DBF23164362
Brand
Endoch
Company
Endoch Inc
Model
DBF-2316OFSC
Catalog number
DBF-2316OFSC
Device description
DISPOSABLE BIOPSY FORCEPS, WITH SPIKE
Published
2019-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCLForceps, Biopsy, Non-Electric
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DBF23164362PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
241382683
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GS3300EndochGS-330GS-3302019-06-01
GS3309EndochGS-330BGS-330B2019-06-01
GS4300EndochGS-430GS-4302019-06-01
GS4307EndochGS-430LGS-430L2019-06-01
GS5000EndochGS-500GS-5002019-06-01
GS5007EndochGS-500LGS-500L2019-06-01
B747EAI0496EndochEAI-0496EAI-04962019-10-01
B747EAI0502EndochEAI-0502EAI-05022019-10-01
B747EAI0503EndochEAI-0503EAI-05032019-10-01
B747EAI0535EndochEAI-0535EAI-05352019-10-01
B747EAI0628EndochEAI-0628EAI-06282019-10-01
B747EAI0784EndochEAI-0784EAI-07842019-10-01
B747EAI0785EndochEAI-0785EAI-07852019-10-01
B747EAI0787EndochEAI-0787EAI-07872019-10-01
B747EAI0788EndochEAI-0788EAI-07882019-10-01
B747EAI0793Endoch EAI-0793EAI-07932019-10-01
DGF23181EndochDGF-2318ADGF-2318A2019-06-03
DGF231858EndochDGF-2318RTDGF-2318RT2019-06-03
DGF23189EndochDGF-2318GDGF-2318G2019-06-03
DGF23231EndochDGF-2323ADGF-2323A2019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900000NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900215NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664900222NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910788NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910801NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910832NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664910863NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911365NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911372NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911389NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664911396NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944035NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944042NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944059NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944066NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944073NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944080NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944097NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944103NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944110NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944127NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944134NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944141NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944165NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06959664944172NAHangzhou AGS MedTech Co., Ltd.FCL2026-07-03
06975339628406Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628413Single-Use Alligator GrasperMacroLux Medical Technology Co., Ltd.HFB2026-07-03
06975339628512Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628529Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03
06975339628536Single-Use Biopsy ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03