EnSite Precision™ H702470

by St. Jude Medical, Inc.

EnSite Precision™ H702470 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K201181 on 26 Jun 2020 (3 earlier submissions) and listed in FDA GUDID since 20 Dec 2016 (UDI-DI 05415067024701), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

+3 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK201181	Date26 Jun 2020Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK183128	Date12 Dec 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK182644	Date19 Oct 2018Decided	StatusActive
United States	GUDID listing	Number05415067024701 UDI-DI	Date20 Dec 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK160210	Date13 Dec 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05415067024701
FDA 510(k) database 510(k) number K201181
FDA 510(k) database 510(k) number K183128
FDA 510(k) database 510(k) number K182644
FDA 510(k) database 510(k) number K160210

Across registries

2 registries list this device

FDA 510(k) K201181 decided 26 Jun 2020 Active· +3 more in the status table
FDA GUDID UDI-DI 05415067024701 listed 20 Dec 2016 Listed

Timeline

5 dated events

13 Dec 2016 Cleared FDA 510(k) K160210
20 Dec 2016 Listed FDA GUDID 05415067024701
19 Oct 2018 Cleared FDA 510(k) K182644
12 Dec 2018 Cleared FDA 510(k) K183128
26 Jun 2020 Cleared FDA 510(k) K201181

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EnSite Precision™
Generic name: Electromagnetic surgical navigation/tracking system
Model / Ref / Catalog: H702470

Primary DI / UDI-DI: 05415067024701
510(k) Number: K160210
K182644
K183128
K201181
FDA product code: DQK
GMDN term: Electromagnetic surgical navigation/tracking system

Device class: Class II
Regulation number: 870.1425
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Convenience kit
Serial number
Manufacturing date

Other properties (11, all answered No)