FDA 510(k)

Phantom XL Insulated Dilators

K-Number: K231691 · 2023-06-29

ApplicantTeDan Surgical Innovations, Inc.

Decision Date2023-06-29

Product CodeGXZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Phantom XL Insulated Dilators is a medical device manufactured by TeDan Surgical Innovations, Inc.. It received FDA 510(k) clearance on 2023-06-29 under approval number K231691. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phantom XL Insulated Dilators?

Phantom XL Insulated Dilators is a medical device that received FDA 510(k) clearance on 2023-06-29. It is manufactured by TeDan Surgical Innovations, Inc.. The 510(k) number is K231691.

When was Phantom XL Insulated Dilators approved by the FDA?

Phantom XL Insulated Dilators received FDA 510(k) clearance on 2023-06-29, under approval number K231691.

What company makes Phantom XL Insulated Dilators?

Phantom XL Insulated Dilators is manufactured by TeDan Surgical Innovations, Inc..

What is the FDA product code for Phantom XL Insulated Dilators?

The FDA product code for Phantom XL Insulated Dilators is GXZ.

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Official Source

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