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FDA 510(k)

Flyte

K-Number: K212655 · 2021-09-21

ApplicantPelvital USA, Inc.
Decision Date2021-09-21
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Flyte is a medical device manufactured by Pelvital USA, Inc.. It received FDA 510(k) clearance on 2021-09-21 under approval number K212655. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flyte?

Flyte is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Pelvital USA, Inc.. The 510(k) number is K212655.

When was Flyte approved by the FDA?

Flyte received FDA 510(k) clearance on 2021-09-21, under approval number K212655.

What company makes Flyte?

Flyte is manufactured by Pelvital USA, Inc..

What is the FDA product code for Flyte?

The FDA product code for Flyte is HIR.

Other Devices by Pelvital USA, Inc.

K200409Pelvital System K210764Flyte K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

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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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