FDA.reportPublic FDA data

BioPince Ultra Full Core Biopsy Instrument

Primary DI
20886333224009
Brand
BioPince Ultra Full Core Biopsy Instrument
Company
ARGON MEDICAL DEVICES, INC.
Model
360-1080-02
Catalog number
360-1080-02
Device description
BioPince™ Ultra Full Core Biopsy Instrument 18ga x 10cm (use with optional Co-Axial Needle: MCXS1810BP)
Published
2019-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K904987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904987000VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)Vibronics1991-02-11KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333224009PackageGS15In Commercial Distribution
00886333224005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633322400920886333224009
00886333224005008863332240058863332240050886333224005

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Away from Sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
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
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
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
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635211CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15