EnCor EnCompass™ ENCPST

Ref ENCPST

EnCor EnCompass™ ENCPST 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 0801741RPLCQVBZ55), cleared under FDA 510(k) K252681 on 12 Dec 2025 and listed in FDA GUDID since 3 Feb 2026 (UDI-DI 00801741234194), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0801741RPLCQVBZ55 Basic UDI-DI 00801741234194UDI-DI	Date25 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00801741234194 UDI-DI	Date3 Feb 2026Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK252681	Date12 Dec 2025Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 0801741RPLCQVBZ55 — open Devices and search for it
AccessGUDID record UDI-DI 00801741234194
FDA 510(k) database 510(k) number K252681

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 0801741RPLCQVBZ55 registered 25 Jun 2026 Active
FDA 510(k) K252681 decided 12 Dec 2025 Active
FDA GUDID UDI-DI 00801741234194 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

12 Dec 2025 Cleared FDA 510(k) K252681
3 Feb 2026 Listed FDA GUDID 00801741234194
25 Jun 2026 Registered EUDAMED 0801741RPLCQVBZ55
20 Aug 2026 Recall initiated FDA recalls Z-3275-2026

Coverage

2 jurisdictions

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Withdrawn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: Mammographic stereotactic biopsy system
Device name: EnCor EnCompass™ Stereotactic Adapter
Model / Ref / Catalog: ENCPST

Primary DI / UDI-DI: 00801741234194
Basic UDI-DI: 0801741RPLCQVBZ55
Direct marketing DI: 00801741234194
510(k) Number: K252681
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
EU registration type: Standard device
EU market of registration: Belgium
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED 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.

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

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Properties

Administering medicine
Prescription use
Serial number
Manufacturing date

Other properties (21, all answered No)