Magnetic Surgical System— 510(k) K190006

Name: FDA 510(k) clearance K190006
Creator: U.S. Food and Drug Administration
Published: 2019-04-29

Substantially Equivalent

Levita Magnetics International Corp

FDA 510(k) clearance K190006 for Magnetic Surgical System, Substantially Equivalent on 2019-04-29. Applicant: Levita Magnetics International Corp. Device class: 2.

Clearance details

Applicant: Levita Magnetics International Corp
Product code: Code PNL
Device class: Class 2
Regulation: 21 CFR 878.4815
Advisory panel: General, Plastic Surgery
Date received: 2019-01-02
Decision date: 2019-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNL

view all

K252435 — Magnetic Surgical System2025-09-26
K250746 — Magnetic Surgical System2025-06-07
K223673 — Surgeon Controlled Arm2023-08-04
K191762 — Magnetic Surgical System2020-04-01
K180894 — Magnetic Surgical System2018-09-19

More clearances from Levita Magnetics International Corp

view all

K171429 — Magnetic Surgical System2017-06-06
DEN150007 — Magnetic Surgical System2016-06-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.