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EnSite™ 100026253

by St. Jude Medical, Inc.

EnSite™ 100026253 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K130594 on 3 May 2013 and listed in FDA GUDID since 21 Apr 2016 (UDI-DI 05414734211239), 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

510(k) K130594

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734211239 UDI-DI Date21 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130594 Date3 May 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130594 decided 3 May 2013 Active
  • FDA GUDID UDI-DI 05414734211239 listed 21 Apr 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130594
  2. Listed FDA GUDID 05414734211239

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EnSite™
Generic name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
100026253
Primary DI / UDI-DI
05414734211239
510(k) Number
FDA product code
DQK
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K130594)

and 2 more cleared under K130594

Similar devices in this category

Other devices filed under Electrical-only medical device connection cable, reusable.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)