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FDA 510(k)

Panther TPS

K-Number: K231825 · 2023-12-15

ApplicantProwess, Inc.
Decision Date2023-12-15
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Panther TPS is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K231825. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther TPS?

Panther TPS is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Prowess, Inc.. The 510(k) number is K231825.

When did Panther TPS receive FDA 510(k) clearance?

Panther TPS received FDA 510(k) clearance on 2023-12-15, under 510(k) number K231825.

Who is the listed applicant for Panther TPS?

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

What is the FDA product code for Panther TPS?

The FDA product code for Panther TPS is MUJ.

Other records listing Prowess, 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.

K211760Panther OISK193459Panther Stereotactic

Related Devices (Code: MUJ)

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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