STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG— 510(k) K990919

Clearance details

Applicant

Visualization Technology, Inc.

Product code

Code LLZ

Device class

Class 2

Regulation

21 CFR 892.2050

Advisory panel

Radiology

Date received

1999-03-18

Decision date

1999-04-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Wilmington, MA, US

• K261855 — Elucid PlaqueIQ2026-09-18
• K254214 — OOOPDS2026-09-15
• K261861 — SPINEsim v1.02026-09-15
• K262060 — 3D-RD-S2026-09-04
• K261500 — KBA3D (v2.4.0)2026-08-17

• K003510 — INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT35002001-02-12
• K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT30002000-03-09
• K983529 — INSTATRAK 30001998-12-31
• K982994 — SKULL BASE INSTATRAK SYSTEM1998-11-16
• K981998 — PEDIATRIC INSTATRAK SYSTEM1998-08-21

Death

13

Total

13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2251-2012 — OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.Class I·Terminated·GE OEC Medical Systems, Inc·20090622

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990919.