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EnCor EnCompass™ ENCPBag

by Bard Peripheral Vascular

Ref ENCPBAG

EnCor EnCompass™ ENCPBag 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 0801741SBDUCFXIUK), cleared under FDA 510(k) K252681 on 12 Dec 2025 and listed in FDA GUDID since 9 Feb 2026 (UDI-DI 10801741234184), active as of 25 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, self-declared

Class I: no certifier involved

510(k) K252681

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741SBDUCFXIUK Basic UDI-DI 10801741234184UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801741234184 UDI-DI Date9 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 0801741SBDUCFXIUK registered 25 Jun 2026 Active
  • FDA 510(k) K252681 decided 12 Dec 2025 Active
  • FDA GUDID UDI-DI 10801741234184 listed 9 Feb 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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 10801741234184
  3. Registered EUDAMED 0801741SBDUCFXIUK
  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

Trade name
EnCor EnCompass EUDAMED
EnCor EnCompass™ GUDID
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Device name
EnCor EnCompass™ Canister Liner Bag
Model / Ref / Catalog
ENCPBag
Primary DI / UDI-DI
10801741234184
Basic UDI-DI
0801741SBDUCFXIUK
Unit of use DI
00801741234187
510(k) Number
FDA product code
KNW
EMDN code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class I 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 Safe

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.

Related devices

Cleared under the same submission (K252681)

and 4 more cleared under K252681

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

  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)