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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 the device name listed in this FDA 510(k) record. The listed applicant is TeDan Surgical Innovations, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) 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. The listed applicant is TeDan Surgical Innovations, Inc.. The 510(k) number is K231691.

When did Phantom XL Insulated Dilators receive FDA 510(k) clearance?

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

Who is the listed applicant for Phantom XL Insulated Dilators?

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

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

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

Other records listing TeDan Surgical Innovations, 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.

K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Related Devices (Code: GXZ)

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.

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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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