Instatrak 3000

510(k) K983529

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK983529	Date31 Dec 1998Cleared	StatusActive

6 recalls · FDA

- Terminated Z-2251-2012 FDA Class I initiated 22 Jun 2009
GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
- Terminated Z-0709-06 FDA Unclassified (pre-2012) initiated 6 Feb 2006
Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
- Terminated Z-0704-2007 FDA Unclassified (pre-2012) initiated 26 Jan 2005
Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
- Terminated Z-0689-05 FDA Unclassified (pre-2012) initiated 13 Dec 2004
Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
2 recalls, same reason
- Terminated Z-0814-05 FDA Unclassified (pre-2012) initiated 12 Jul 2004
- Terminated Z-0815-05 FDA Unclassified (pre-2012) initiated 12 Jul 2004
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

1 jurisdiction

United States — FDA 510(k) Active

510(k)