DeviceClearance

kallisio stentra oral stent— 510(k) K232293

Substantially Equivalent

Kallisio, Inc.

FDA 510(k) clearance K232293 for kallisio stentra oral stent, Substantially Equivalent on 2023-12-22. Applicant: Kallisio, Inc.. Device class: 2.

Clearance details

Applicant
Kallisio, Inc.
Product code
Code IYE
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IYE

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Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

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 →

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