DeviceClearance

TILITE YG AND TILITE YGS— 510(k) K023606

Substantially Equivalent

Tisport

FDA 510(k) clearance K023606 for TILITE YG AND TILITE YGS, Substantially Equivalent on 2002-11-19. Applicant: Tisport. Device class: 1.

Clearance details

Applicant
Tisport
Product code
Code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kennewick, WA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Tisport

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Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

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

Recalls naming K023606

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023606.

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