Instrument Exit Point on Touch Surgery Aide— 510(k) K253984
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K253984 for Instrument Exit Point on Touch Surgery Aide, Substantially Equivalent on 2026-06-04. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code SFE
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.