FDA.reportPublic FDA data

SemiCut

Primary DI
08052440105861
Brand
SemiCut
Company
M.D.L. S.R.L.
Model
PD01615
Catalog number
PD01615
Device description
DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 16G X 150 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER
Published
2021-04-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K160316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160316000SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L.2016-10-27KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052440105861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052440105861080524401058618052440105861

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
447228586
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032986359416AutoMarkPNA2005PNA20052017-01-05
08032986359447AutoMarkPNAX2005PNAX20052017-01-05
08032986359867RepoMarkPR2005PR20052017-01-05
08052440107407MarkPNX2007PNX20072017-06-05
08052440107445MarkPNX2010PNX20102017-02-21
08052440107469MarkPN2012PN20122017-03-23
08052440107759AutoMarkPNAX2010PNAX20102017-06-05
08052440107841RepoMarkPR2007PR20072017-01-05
08052440107858RepoMarkPR2010PR20102017-06-05
08056138586222MarkPN2010PN20102021-05-14
08056138586239MarkPN2012PN20122021-05-14
08056138586246MarkPN2015PN20152021-05-17
08056138586253AutoMarkPNA2005PNA20052021-05-17
08056138586260AutoMarkPNA2010PNA20102021-05-17
08056138586277AutoMarkPNA2015PNA20152021-05-17
08056138586307MarkSlimPNS2010PNS20102021-05-17
08056138586314MarkslimPNS2015PNS20152021-05-17
08056138586369RepoMarkPR2007PR20072021-05-17
08056138586376RepoMarkPR2010PR20102021-05-17
08056138586383RepoMarkPR2015PR20152021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10884521833043SharkCoreCovidien LPFCG2026-09-06
10884521833050SharkCoreCovidien LPFCG2026-09-06
10884521833067SharkCoreCovidien LPFCG2026-09-06
10884521833074SharkCoreCovidien LPFCG2026-09-06
10884521833081SharkCoreCovidien LPFCG2026-09-06
10884521833012BeaconCovidien LPFCG2026-09-05
10884521833029BeaconCovidien LPFCG2026-09-05
10884521833036BeaconCovidien LPFCG2026-09-05
10884521833142BeaconCovidien LPFCG2026-09-05
10884521833159BeaconCovidien LPFCG2026-09-05
10884521833166BeaconCovidien LPFCG2026-09-05
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00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
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06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15