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FDA 510(k)

Panther Stereotactic

K-Number: K193459 · 2020-04-27

ApplicantProwess, Inc.
Decision Date2020-04-27
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Panther Stereotactic is the device name listed in this FDA 510(k) record. The listed applicant is Prowess, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K193459. 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 Stereotactic?

Panther Stereotactic is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Prowess, Inc.. The 510(k) number is K193459.

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

Panther Stereotactic received FDA 510(k) clearance on 2020-04-27, under 510(k) number K193459.

Who is the listed applicant for Panther Stereotactic?

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 Stereotactic?

The FDA product code for Panther Stereotactic 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.

K231825Panther TPSK211760Panther OIS

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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