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Disposable Passive Array - Blunt Probe MP1000-CM

by Izi Medical Products LLC

Disposable Passive Array - Blunt Probe MP1000-CM is a Class II device made by Izi Medical Products LLC, cleared under FDA 510(k) K142344 on 20 Mar 2015 and listed in FDA GUDID since 26 Jan 2017 (UDI-DI 00815212022159), 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) K142344

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 Number00815212022159 UDI-DI Date26 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142344 Date20 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142344 decided 20 Mar 2015 Active
  • FDA GUDID UDI-DI 00815212022159 listed 26 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142344
  2. Listed FDA GUDID 00815212022159

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Disposable Passive Array - Blunt Probe
Generic name
Neurological stereotactic surgery system
Model / reference
MP1000-CM
Primary DI / UDI-DI
00815212022159
510(k) Number
FDA product code
HAW
GMDN term
Neurological stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neurological stereotactic surgery system

Cleared under the same submission (K142344)

and 8 more cleared under K142344

Similar devices in this category

Other devices filed under Neurological stereotactic surgery system.

Other devices from Izi Medical Products LLC

See all devices from Izi Medical Products LLC →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)