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

FDA 510(k)

Resection Electrodes

K-Number: K161600 · 2016-09-06

Decision Date2016-09-06
Product CodeJOS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Resection Electrodes is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-09-06 under approval number K161600. The device is classified under product code JOS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resection Electrodes?

Resection Electrodes is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K161600.

When was Resection Electrodes approved by the FDA?

Resection Electrodes received FDA 510(k) clearance on 2016-09-06, under approval number K161600.

What company makes Resection Electrodes?

Resection Electrodes is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for Resection Electrodes?

The FDA product code for Resection Electrodes is JOS.

Related Clinical Trials

Other Devices by Olympus Winter & Ibe GmbH

View all 21 devices →

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.