FDA.reportPublic FDA data

Zinnanti Surgical

Primary DI
G373144005J0
Brand
Zinnanti Surgical
Company
Zinnanti Surgical Design Group Inc
Model
14-4005J
Device description
J-Tip Biopsy Cartridge
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K892252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K892252000BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-10-03FCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G373144005J0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078579514
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G3731331500Zinnanti Surgical13-31502026-06-10
G373ZS250Zinnanti Surgical ZS252026-04-09
G373ZSE250Zinnanti SurgicalZSE252026-04-09
G3731433010Zinnanti Surgical14-33012026-03-04
G373131023DB0Zinnanti Surgical13-1023DB2026-01-27
G373131023DS0Zinnanti Surgical13-1023DS2026-01-27
G373Z13000Zinnanti SurgicalZ-13002026-01-15
G373144010HB0Zinnanti Surgical14-4010-HB2025-07-29
G3731431000Zinnanti Surgical14-31002025-06-30
G3731431500Zinnanti Surgical14-31502025-06-30
G373DM00300Diagnostic MedicalDM00302025-02-25
G373DM25100Diagnostic MedicalDM25102025-02-25
G373DS10080Diagnostic MedicalDS10082025-02-25
G373144051ESU0Zinnanti Surgical14-4051ESU2024-12-11
G3731440140Zinnanti Surgical14-40142024-10-09
G373144051DHB0Zinnanti Surgical14-4051DHB2024-09-13
G3731440150Zinnanti Surgical14-40152024-08-23
G373144017HB0Zinnanti Surgical 14-4017HB2024-08-23
G3731401100Zinnanti Surgical14-01102024-08-14
G3731401150Zinnanti Surgical14-01152024-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD13024290Surgical DirectSurgical Direct, Inc.FCL2026-07-14
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
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
06975339628550Single-Use Grasping ForcepsMacroLux Medical Technology Co., Ltd.FCL2026-07-03