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Probe Cover Kits 1464

by Protek Medical Products, Inc.

Probe Cover Kits 1464 is a Class II device made by Protek Medical Products, Inc., cleared under FDA 510(k) K970889 on 20 Oct 1997 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 10841912102928), 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) K970889

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 Number10841912102928 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970889 Date20 Oct 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970889 decided 20 Oct 1997 Active
  • FDA GUDID UDI-DI 10841912102928 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K970889
  2. Listed FDA GUDID 10841912102928

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Probe Cover Kits
Generic name
Cable/lead/sensor/probe cover, sterile
Model / reference
1464
Primary DI / UDI-DI
10841912102928
510(k) Number
FDA product code
KKX
GMDN term
Cable/lead/sensor/probe cover, sterile
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cable/lead/sensor/probe cover, sterile

Cleared under the same submission (K970889)

and 8 more cleared under K970889

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)