TSX PROBE, OCULAR CONTACT PROBE; TSX PROBE,OCULAR CONTACT PROBE,SMA— 510(k) K992508

Name: FDA 510(k) clearance K992508
Creator: U.S. Food and Drug Administration
Published: 1999-08-19

Substantially Equivalent

Instruments For Medicine and Diagnostics

FDA 510(k) clearance K992508 for TSX PROBE, OCULAR CONTACT PROBE; TSX PROBE,OCULAR CONTACT PROBE,SMA, Substantially Equivalent on 1999-08-19. Applicant: Instruments For Medicine and Diagnostics. Device class: 2.

Clearance details

Device name as filed: TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA
Applicant: Instruments For Medicine and Diagnostics
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1999-07-27
Decision date: 1999-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.