FDA 510(k)

Spartan eCoil System

K-Number: K180653 · 2018-12-04

Decision Date2018-12-04

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Spartan eCoil System is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Micro, Inc.. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K180653. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spartan eCoil System?

Spartan eCoil System is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Spartan Micro, Inc.. The 510(k) number is K180653.

When did Spartan eCoil System receive FDA 510(k) clearance?

Spartan eCoil System received FDA 510(k) clearance on 2018-12-04, under 510(k) number K180653.

Who is the listed applicant for Spartan eCoil System?

The FDA 510(k) record lists Spartan Micro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spartan eCoil System?

The FDA product code for Spartan eCoil System is HCG.

Other records listing Spartan Micro, Inc. 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.

K220716Spartan SC 069 K220075Spartan Center Wire K213451Spartan MC 0165

Related Devices (Code: HCG)

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.