FDA.reportPublic FDA data

AprioCore plus

Primary DI
17350031350125
Brand
AprioCore plus
Company
Apriomed AB
Model
ACP16-135-10
Catalog number
ACP16-135-10
Device description
AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
Published
2020-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K193268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193268000APrioCore PlusApriomed AB2020-02-27KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350031350125PackageGS15In Commercial Distribution
27350031350122PackageGS112In Commercial Distribution
07350031350128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735003135012517350031350125
2735003135012227350031350122
07350031350128073500313501287350031350128

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small 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, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge16Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46184301440info@apriomed.com

Regulatory Flags#

DUNS number
631734758
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
07350031350623Bonopty Penetration Set10-106210-10622020-12-02
07350031350630Bonopty Biopsy Set10-106310-10632020-12-01
07350031350722Bonopty Penetration Set10-107210-10722020-12-04
07350031350739Bonopty Biopsy Set10-107310-10732020-12-04
07350031350746Bonopty Extended Drill10-107410-10742020-12-04
07350031350821Bonopty Penetration Set10-108210-10822020-12-04
07350031350838Bonopty Biopsy Set10-108310-10832020-12-04
07350031351194Gangi-SoftGuard Coaxial NeedleSG12-121SG12-1212019-01-21
07350031351217Gangi-SoftGuard Coaxial NeedleSG13-071SG13-0712019-01-21
07350031351224Gangi-SoftGuard Coaxial NeedleSG13-121SG13-1212019-01-21
07350031351231Gangi-SoftGuard Coaxial NeedleSG13-171SG13-1712019-01-21
07350031351248Gangi-SoftGuard Coaxial NeedleSG15-071SG15-0712019-01-21
07350031351255Gangi-SoftGuard Coaxial NeedleSG15-121SG15-1212019-01-21
07350031351262Gangi-SoftGuard Coaxial NeedleSG15-171SG15-1712019-01-21
07350031351279Gangi-SoftGuard Coaxial NeedleSG17-071SG17-0712019-01-21
07350031351286Gangi-SoftGuard Coaxial NeedleSG17-121SG17-1212019-01-21
07350031351293Gangi-SoftGuard Coaxial NeedleSG17-171SG17-1712019-01-21
07350031351330Gangi-HydroGuard Coaxial NeedleHG15-121HG15-1212019-01-21
07350031351347Gangi-HydroGuard Coaxial NeedleHG15-171HG15-1712019-01-21
07350031351354Gangi-HydroGuard Coaxial NeedleHG17-121HG17-1212019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
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