FDA.reportPublic FDA data

EnCor EnCompass™

Primary DI
10801741234139
Brand
EnCor EnCompass™
Company
Bard Peripheral Vascular, Inc.
Model
ENCP7GBT
Catalog number
ENCP7GBT
Device description
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 7G, Blunt Tip
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
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
10801741234139PackageGS15In Commercial Distribution
00801741234132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174123413910801741234139
00801741234132008017412341328017412341320801741234132

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 Gauge7Gauge

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
135057938
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
false
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
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
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
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
06937278630643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630841CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630858CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630865CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630872CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630889CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630896CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630902CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630919CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630926CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631046CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631053CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631060CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631077CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631084CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631091CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631107CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631114CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631138CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631145CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08