Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Magnetic Surgical System

K-Number: K171429 · 2017-06-06

Decision Date2017-06-06
Product CodePNL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Magnetic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Levita Magnetics International Corp. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K171429. The device is classified under product code PNL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magnetic Surgical System?

Magnetic Surgical System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Levita Magnetics International Corp. The 510(k) number is K171429.

When did Magnetic Surgical System receive FDA 510(k) clearance?

Magnetic Surgical System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K171429.

Who is the listed applicant for Magnetic Surgical System?

The FDA 510(k) record lists Levita Magnetics International Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magnetic Surgical System?

The FDA product code for Magnetic Surgical System is PNL.

Other records listing Levita Magnetics International Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: PNL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.