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9735521ENT

by Medtronic Navigation Inc. 2 variants

9735521ENT is a Class II device made by Medtronic Navigation Inc., cleared under FDA 510(k) K162309 on 31 Mar 2017 and listed in FDA GUDID since 1 Oct 2020 (UDI-DI 00763000385545), active as of 8 Nov 2026. 2 FDA recalls are 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

1 ongoing

This device is named in the recall

Documents

510(k) K162309

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000385545 UDI-DI Date1 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162309 Date31 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162309 decided 31 Mar 2017 Active
  • FDA GUDID UDI-DI 00763000385545 listed 1 Oct 2020 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1776-2024 FDA Class I initiated 26 Mar 2024

    Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

    • Terminated Z-1995-2020 FDA Class I initiated 9 Aug 2019

    Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

Timeline

4 dated events

  1. Cleared FDA 510(k) K162309
  2. Recall initiated FDA recalls Z-1995-2020
  3. Listed FDA GUDID 00763000385545
  4. Recall initiated FDA recalls Z-1776-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Multi-purpose stereotactic surgery system
Model / reference
9735521ENT
Primary DI / UDI-DI
00763000385545
510(k) Number
FDA product code
HAW
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-purpose stereotactic surgery system

Cleared under the same submission (K162309)

and 8 more cleared under K162309

Similar devices in this category

Other devices filed under Multi-purpose stereotactic surgery system.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

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