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Henry Schein 9004251

by Henry Schein, Inc.

Henry Schein 9004251 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K052622 on 9 Dec 2005 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040004944), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K052622

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 Number00304040004944 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052622 Date9 Dec 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052622 decided 9 Dec 2005 Active
  • FDA GUDID UDI-DI 00304040004944 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0810-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006

    The product label fails to warn users to use the device on patients with shielded pacemakers only.

Timeline

3 dated events

  1. Cleared FDA 510(k) K052622
  2. Recall initiated FDA recalls Z-0810-06
  3. Listed FDA GUDID 00304040004944

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Electrosurgical system
Model / Ref / Catalog
9004251
Primary DI / UDI-DI
00304040004944
510(k) Number
FDA product code
EKZ
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
872.4920
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 0.0625 Inch

Related devices

Category: Electrosurgical system

Cleared under the same submission (K052622)

and 8 more cleared under K052622

Similar devices in this category

Other devices filed under Electrosurgical system.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

Other properties (15, all answered No)