Smith+Nephew INTELLIO Tablet— 510(k) K221929

Substantially Equivalent

Smith+Nephew

FDA 510(k) clearance K221929 for Smith+Nephew INTELLIO Tablet, Substantially Equivalent on 2022-09-06. Applicant: Smith+Nephew. Device class: 2.

Clearance details

Applicant: Smith+Nephew
Product code: Code ODA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-01
Decision date: 2022-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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