Forsvall biopsy needle

Primary DI
07350181060045
Brand
Forsvall biopsy needle
Company
Xaga Surgical AB
Model
Mech-00286
Catalog number
24171-14-04
Device description
The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. TheForsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle issingle use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissuesamples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainlessmedical grade steel.
Published
2025-06-02
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

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242128000Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)Xaga Surgical2025-02-27KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350181060059PackageGS15In Commercial Distribution
27350181060063PackageGS118In Commercial Distribution
07350181060045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735018106005917350181060059
2735018106006327350181060063
07350181060045073501810600457350181060045

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun needleAn invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) 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 is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.

Regulatory Flags#

DUNS number
352977261
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350181060076Forsvall biopsy gunMech-0066924171-07-022025-06-09
07309861000079Forsvall biopsy gunMech-0066924171-07-022025-06-09
07309861000048Forsvall biopsy needleMech-0028624171-14-042025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033860001926BIOPSYBELL SRLBIOPSYBELL SRLKNW2023-10-23
08033860000141BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000189BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000240BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000264BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000448BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000462BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000547BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000585BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860001087BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860002664BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860005290BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860005597BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860010393BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000080BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000103BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000127BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000165BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000523BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860001063BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860003142BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860004255BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860004453BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860009311BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860001681BIOPSYBELL SRLBIOPSYBELL SRLKNW2023-08-31
08033860002909BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860002961BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003203BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003401BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003777BiopsybellBIOPSYBELL SRLKNW2023-08-31