FDA.reportPublic FDA data

SureAim Coaxial Biopsy Needle

Primary DI
06954414646191
Brand
SureAim Coaxial Biopsy Needle
Company
Canyon Medical Inc.
Model
CN-19/59
Device description
Coaxial Biopsy Needle
Published
2023-06-23
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
K222865000
K233031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222865000M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy NeedleCanyon Medical, Inc.2023-04-03KNW
K233031000M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy NeedleCanyon Medical, Inc.2024-01-17KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954414646191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414646191069544146461916954414646191

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527310648
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954414670110Polyvinyl Alcohol Embolic MicrospheresPB-1012026-02-26
06954414670127Polyvinyl Alcohol Embolic MicrospheresPB-1022026-02-26
06954414670134Polyvinyl Alcohol Embolic MicrospheresPB-1032026-02-26
06954414670141Polyvinyl Alcohol Embolic MicrospheresPB-2012026-02-26
06954414670158Polyvinyl Alcohol Embolic MicrospheresPB-2022026-02-26
06954414670165Polyvinyl Alcohol Embolic MicrospheresPB-2032026-02-26
06954414670172Polyvinyl Alcohol Embolic MicrospheresPB-4012026-02-26
06954414670189Polyvinyl Alcohol Embolic MicrospheresPB-4022026-02-26
06954414670196Polyvinyl Alcohol Embolic MicrospheresPB-4032026-02-26
06954414670202Polyvinyl Alcohol Embolic MicrospheresPB-6012026-02-26
06954414670219Polyvinyl Alcohol Embolic MicrospheresPB-6022026-02-26
06954414670226Polyvinyl Alcohol Embolic MicrospheresPB-6032026-02-26
06954414670233Polyvinyl Alcohol Embolic MicrospheresPB-8012026-02-26
06954414670240Polyvinyl Alcohol Embolic MicrospheresPB-8022026-02-26
06954414670257Polyvinyl Alcohol Embolic MicrospheresPB-8032026-02-26
06954414670264Polyvinyl Alcohol Embolic MicrospheresPB-10512026-02-26
06954414670271Polyvinyl Alcohol Embolic MicrospheresPB-10522026-02-26
06954414670288Polyvinyl Alcohol Embolic MicrospheresPB-10532026-02-26
06954414670295Polyvinyl Alcohol Embolic MicrospheresPW-1012026-02-26
06954414670301Polyvinyl Alcohol Embolic MicrospheresPW-1022026-02-26

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