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EnSite™ ENSITE-FF-01

by St. Jude Medical, Inc.

Ref ENSITE-FF-01

EnSite™ ENSITE-FF-01 is a device classified as Class IIb in the EU and Class II in the US made by St. Jude Medical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 5414734DMC0037CS), cleared under FDA 510(k) K242016 on 9 Aug 2024 (4 earlier submissions) and listed in FDA GUDID since 6 Jan 2021 (UDI-DI 05415067032195), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242016

+4 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMC0037CS Basic UDI-DI 05415067032195UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK242016 Date9 Aug 2024DecidedStatusActive
United StatesGUDID listing GUDID Number05415067032195 UDI-DI Date6 Jan 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734DMC0037CS registered 28 Aug 2026 Active
  • FDA 510(k) K242016 decided 9 Aug 2024 Active· +4 more in the status table
  • FDA GUDID UDI-DI 05415067032195 listed 6 Jan 2021 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K202066
  2. Listed FDA GUDID 05415067032195
  3. Cleared FDA 510(k) K221213
  4. Cleared FDA 510(k) K223094
  5. Cleared FDA 510(k) K231415
  6. Cleared FDA 510(k) K242016
  7. Registered EUDAMED 5414734DMC0037CS

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  • Withdrawn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
EnSite™
Generic name
Electromagnetic surgical navigation/tracking system
Device name
EnSite X EP System
Model / Ref / Catalog
ENSITE-FF-01
Primary DI / UDI-DI
05415067032195
Basic UDI-DI
5414734DMC0037CS
510(k) Number
FDA product code
DQK
EMDN code
Z12059080 Various instruments for cardiology and cardiac surgery - hardware accessories
GMDN term
Electromagnetic surgical navigation/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

Category: Electromagnetic surgical navigation device tracking system

Cleared under the same submission (K202066)

and 8 more cleared under K202066

Cleared under the same submission (K221213)

and 8 more cleared under K221213

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

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