Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis— 510(k) K182272

Name: FDA 510(k) clearance K182272
Creator: U.S. Food and Drug Administration
Published: 2019-04-15

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K182272 for Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis, Substantially Equivalent on 2019-04-15. Applicant: Sterilmed, Inc.. Device class: Unclassified.

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code NLQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-08-22
Decision date: 2019-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.