Cianna Medical SAVI Scout Reflector and SAVI Scout System— 510(k) K161507

Name: FDA 510(k) clearance K161507
Creator: U.S. Food and Drug Administration
Published: 2016-07-29

Substantially Equivalent

Cianna Medical, Inc.

FDA 510(k) clearance K161507 for Cianna Medical SAVI Scout Reflector and SAVI Scout System, Substantially Equivalent on 2016-07-29. Applicant: Cianna Medical, Inc.. Device class: 2.

Clearance details

Applicant: Cianna Medical, Inc.
Product code: Code PDW
Device class: Class 2
Regulation: 21 CFR 878.4670
Advisory panel: General, Plastic Surgery
Date received: 2016-06-01
Decision date: 2016-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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K081677 — SAVI APPLICATOR KIT2008-07-22

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