InstruSafe Instrument Protection System— 510(k) K210836

Name: FDA 510(k) clearance K210836
Creator: U.S. Food and Drug Administration
Published: 2021-11-30

Substantially Equivalent

Summitt Medical, LLC

FDA 510(k) clearance K210836 for InstruSafe Instrument Protection System, Substantially Equivalent on 2021-11-30. Applicant: Summitt Medical, LLC. Device class: 2.

Clearance details

Applicant: Summitt Medical, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2021-03-22
Decision date: 2021-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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