FDA.reportPublic FDA data

EnCor EnCompass™

Primary DI
00801741234149
Brand
EnCor EnCompass™
Company
Bard Peripheral Vascular, Inc.
Model
ENCP10GBT
Catalog number
ENCP10GBT
Device description
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 10G, Blunt Tip
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K252681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252681000EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.2025-12-12KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741234146PackageGS15In Commercial Distribution
00801741234149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174123414610801741234146
00801741234149008017412341498017412341490801741234149

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge10Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@BD.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28
10801741234146EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28

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
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636256CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31