Instrument Exit Point on Touch Surgery Aide— 510(k) K253984

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K253984 for Instrument Exit Point on Touch Surgery Aide, Substantially Equivalent on 2026-06-04. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code SFE
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-12
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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