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Cinch™ 1194

by St. Jude Medical, Inc.

Cinch™ 1194 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K081208 on 18 Jul 2008 and listed in FDA GUDID since 15 Apr 2015 (UDI-DI 05414734400688), 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) K081208

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 Number05414734400688 UDI-DI Date15 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081208 Date18 Jul 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081208 decided 18 Jul 2008 Active
  • FDA GUDID UDI-DI 05414734400688 listed 15 Apr 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081208
  2. Listed FDA GUDID 05414734400688

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cinch™
Generic name
Electrical cable/lead holder
Model / Ref / Catalog
1194
Primary DI / UDI-DI
05414734400688
510(k) Number
FDA product code
GZF, GZB
GMDN term
Electrical cable/lead holder
Device class
Class II
Regulation number
882.5870, 882.5880
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GZF (STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)).

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)