FDA.reportPublic FDA data

Inrad

Primary DI
00817295021142
Brand
Inrad
Company
Inrad
Model
640914
Catalog number
640914
Device description
AccuCore Single Action Core Biopsy Device 14g x 9cm
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000612000ACCUCORE SINGLE ACTION CORE BIOPSY DEVICEInrad2000-04-24KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817295021142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817295021142008172950211428172950211420817295021142

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Regulatory Flags#

DUNS number
940023385
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817295020008Inrad15423154232026-10-08
00817295020015Inrad15425154252026-10-08
00817295020022Inrad54818541812026-10-08
00817295020039Inrad54820548202026-10-08
00817295020046Inrad54822548222026-10-08
00817295020053Inrad54720547202026-10-08
00817295020060Inrad54722547222026-10-08
00817295020077Inrad54922549222026-10-08
00817295020107Inrad53722537222026-10-08
00817295020114Inrad53922539222026-10-08
00817295020121Inrad53822538222026-10-08
00817295020152Inrad53820538202026-10-08
00817295020169Inrad53720537202026-10-08
00817295020176Inrad53818538182026-10-08
00817295021081Inrad6209166209162026-10-08
00817295021098Inrad6209186209182026-10-08
00817295021104Inrad6209206209202026-10-08
00817295021111Inrad6215166215162026-10-08
00817295021128Inrad6215186215182026-10-08
00817295021135Inrad6215206215202026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295021081InradInradKNW2026-10-08
00817295021081InradInradFCG2026-10-08
00817295021098InradInradFCG2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021388InradInradFCG2026-10-08
00817295021388InradInradKNW2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884521833098SharkCoreCovidien LPFCG2026-10-01
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22