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Chalgren 110-725-1

by Chalgren Enterprises, Inc.

Chalgren 110-725-1 is a Class II device made by Chalgren Enterprises, Inc., cleared under FDA 510(k) K912283 on 16 Mar 1992 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00816020020009), active as of 22 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) K912283

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816020020009 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK912283 Date16 Mar 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K912283 decided 16 Mar 1992 Active
  • FDA GUDID UDI-DI 00816020020009 listed 9 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2446-2010 FDA Unclassified (pre-2012) initiated 12 Apr 2007

    Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.

Timeline

3 dated events

  1. Cleared FDA 510(k) K912283
  2. Recall initiated FDA recalls Z-2446-2010
  3. Listed FDA GUDID 00816020020009

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Chalgren
Generic name
Electromyographic needle electrode, single-use
Model / Ref / Catalog
110-725-1, 110-725
Primary DI / UDI-DI
00816020020009
510(k) Number
FDA product code
IKT
GMDN term
Electromyographic needle electrode, single-use
Device class
Class II
Regulation number
890.1385
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
Size
Needle Gauge — 25 Gauge

Related devices

Category: Electromyographic needle electrode, single-use

Cleared under the same submission (K912283)

and 1 more cleared under K912283

Similar devices in this category

Other devices filed under Electromyographic needle electrode, single-use.

Other devices from Chalgren Enterprises, Inc.

See all devices from Chalgren Enterprises, Inc. →

Properties

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