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StealthConnect 9735696

by Medtronic Navigation Inc.

StealthConnect 9735696 is a Class II device made by Medtronic Navigation Inc., cleared under FDA 510(k) K162655 on 21 Apr 2017 and listed in FDA GUDID since 15 Apr 2018 (UDI-DI 00643169705432), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K162655

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 Number00643169705432 UDI-DI Date15 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162655 Date21 Apr 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162655 decided 21 Apr 2017 Active
  • FDA GUDID UDI-DI 00643169705432 listed 15 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162655
  2. Listed FDA GUDID 00643169705432

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
StealthConnect
Generic name
Stereotactic system application software
Model / reference
9735696
Primary DI / UDI-DI
00643169705432
510(k) Number
FDA product code
HAW
GMDN term
Stereotactic system application software
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stereotactic system application software

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (12, all answered No)