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EnCor EnCompass

by Bard Peripheral Vascular, Inc.

Ref ENCPFS

EnCor EnCompass (ENCPFS) is a device classified as Class I in the EU and Class II in the US made by Bard Peripheral Vascular, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI 0801741RLHJUUTO5H), cleared under FDA 510(k) K252681 on 12 Dec 2025 and listed in FDA GUDID since 3 Feb 2026 (UDI-DI 00801741234262), active as of 22 Oct 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252681

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741RLHJUUTO5H Basic UDI-DI 00801741234262UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741234262 UDI-DI Date3 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK252681 Date12 Dec 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0801741RLHJUUTO5H registered 25 Jun 2026 Active
  • FDA 510(k) K252681 decided 12 Dec 2025 Active
  • FDA GUDID UDI-DI 00801741234262 listed 3 Feb 2026 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3275-2026 FDA Class II initiated 20 Aug 2026

    Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.

Timeline

4 dated events

  1. Cleared FDA 510(k) K252681
  2. Listed FDA GUDID 00801741234262
  3. Registered EUDAMED 0801741RLHJUUTO5H
  4. Recall initiated FDA recalls Z-3275-2026

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

Generic name
Mammographic stereotactic biopsy system
Device name
EnCor EnCompass™ Foot Switch
Model / Ref / Catalog
ENCPFS
Primary DI / UDI-DI
00801741234262
Basic UDI-DI
0801741RLHJUUTO5H
Direct marketing DI
00801741234262
510(k) Number
FDA product code
KNW
EMDN code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
GMDN term
Mammographic stereotactic biopsy system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1075
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000017556
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Similar devices in this category

Other devices filed under NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER.

Other devices from Bard Peripheral Vascular

See all devices from Bard Peripheral Vascular →

Properties

  • Administering medicine
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)