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EnCor EnCompass™ ENCP7GVLOC

by Bard Peripheral Vascular

Ref ENCP7GVLOC

EnCor EnCompass™ ENCP7GVLOC is a device classified as Class IIa in the EU and Class II in the US made by Bard Peripheral Vascular, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI 0801741RXKDSFVU8T), cleared under FDA 510(k) K161805 on 19 Jul 2016 and listed in FDA GUDID since 30 Jan 2026 (UDI-DI 00801741234200), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161805

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741RXKDSFVU8T Basic UDI-DI 00801741234200UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741234200 UDI-DI Date30 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK161805 Date19 Jul 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0801741RXKDSFVU8T registered 25 Jun 2026 Active
  • FDA 510(k) K161805 decided 19 Jul 2016 Active
  • FDA GUDID UDI-DI 00801741234200 listed 30 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161805
  2. Listed FDA GUDID 00801741234200
  3. Registered EUDAMED 0801741RXKDSFVU8T

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
EnCor EnCompass VISILOC EUDAMED
EnCor EnCompass™ GUDID
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Device name
EnCor EnCompass™ VisiLoc™ MRI Introducer Set
Model / Ref / Catalog
ENCP7GVLOC
Primary DI / UDI-DI
00801741234200
Basic UDI-DI
0801741RXKDSFVU8T
510(k) Number
FDA product code
KNW
EMDN code
A0102010101 Shearing biopsy needles
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Needle Gauge — 7 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K161805)

Similar devices in this category

Other devices filed under SHEARING BIOPSY NEEDLES.

Other devices from Bard Peripheral Vascular

See all devices from Bard Peripheral Vascular →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)