EnSite Precision™ EN0020-P

by St. Jude Medical, Inc.

EnSite Precision™ EN0020-P is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K160210 on 13 Dec 2016 and listed in FDA GUDID since 20 Dec 2016 (UDI-DI 15415067025934), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number15415067025934 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 15415067025934
FDA 510(k) database 510(k) number K160210

Across registries

2 registries list this device

FDA 510(k) K160210 decided 13 Dec 2016 Active
FDA GUDID UDI-DI 15415067025934 listed 20 Dec 2016 Listed

Timeline

2 dated events

13 Dec 2016 Cleared FDA 510(k) K160210
20 Dec 2016 Listed FDA GUDID 15415067025934

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EnSite Precision™
Generic name: Cardiac mapping system reference patch
Model / Ref / Catalog: EN0020-P

Primary DI / UDI-DI: 15415067025934
510(k) Number: K160210
FDA product code: DQK
GMDN term: Cardiac mapping system reference patch

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

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Properties

Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (10, all answered No)