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FDA 510(k)

L360 Thigh System

K-Number: K191587 · 2019-09-12

ApplicantBioness, Inc.
Decision Date2019-09-12
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

L360 Thigh System is a medical device manufactured by Bioness, Inc.. It received FDA 510(k) clearance on 2019-09-12 under approval number K191587. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L360 Thigh System?

L360 Thigh System is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Bioness, Inc.. The 510(k) number is K191587.

When was L360 Thigh System approved by the FDA?

L360 Thigh System received FDA 510(k) clearance on 2019-09-12, under approval number K191587.

What company makes L360 Thigh System?

L360 Thigh System is manufactured by Bioness, Inc..

What is the FDA product code for L360 Thigh System?

The FDA product code for L360 Thigh System is GZI.

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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.

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