Leva Pelvic Health System— 510(k) K212495

Substantially Equivalent

Renovia, Inc.

FDA 510(k) clearance K212495 for Leva Pelvic Health System, Substantially Equivalent on 2021-09-08. Applicant: Renovia, Inc.. Device class: 2.

Clearance details

Applicant: Renovia, Inc.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-09
Decision date: 2021-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, 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.