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Chalgren 293-2-36STP

by Chalgren Enterprises, Inc.

Chalgren 293-2-36STP is a Class II device made by Chalgren Enterprises, Inc., cleared under FDA 510(k) K953356 on 22 Jan 1996 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00816020020726), active as of 22 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 22 Oct 2026

Documents

510(k) K953356

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 Number00816020020726 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953356 Date22 Jan 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953356 decided 22 Jan 1996 Active
  • FDA GUDID UDI-DI 00816020020726 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K953356
  2. Listed FDA GUDID 00816020020726

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  • Withdrawn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
Analytical non-scalp cutaneous lead
Model / Ref / Catalog
293-2-36STP
Primary DI / UDI-DI
00816020020726
510(k) Number
FDA product code
GXY
GMDN term
Analytical non-scalp cutaneous lead
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution
Size
Length — 36 Inch

Related devices

Category: Analytical non-scalp cutaneous lead

Cleared under the same submission (K953356)

and 3 more cleared under K953356

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Chalgren Enterprises, Inc.

See all devices from Chalgren Enterprises, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)