# K990919: Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight Aspirator,13.9 CM Strag

- Pathway: 510(k) (Special)
- Applicant: Visualization Technology, Inc.
- Decided: Apr 15, 1999 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911783 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
5 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960330: Instatrak, Visualization Technology, Inc. (1996) Summary page 1.
- K981998: Pediatric Instatrak System, Visualization Technology, Inc. (1998) Summary page 1.
- K982994: Skull Base Instatrak System, Visualization Technology, Inc. (1998) Summary page 1.
- K983529: Instatrak 3000, Visualization Technology, Inc. (1998) Summary page 1.

## Recalls of this device
- Jun 22, 2009 · Class I · Z-2251-2012: 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 Su

## Indications for use
The aspirators and pointers are accessories of the previously cleared InstaTrak 3000 System, (K983529) and therefore have the same intended use. The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

Source page: https://510kreport.com/device/K990919
Methodology: https://510kreport.com/methodology