FDA 510(k)

Pro-Tx Endorectal Balloon (PROT-25)

K-Number: K223249 · 2023-02-10

Decision Date2023-02-10

Product CodePCT

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Pro-Tx Endorectal Balloon (PROT-25) is the device name listed in this FDA 510(k) record. The listed applicant is Dxtx Medical, Inc.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223249. The device is classified under product code PCT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pro-Tx Endorectal Balloon (PROT-25)?

Pro-Tx Endorectal Balloon (PROT-25) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Dxtx Medical, Inc.. The 510(k) number is K223249.

When did Pro-Tx Endorectal Balloon (PROT-25) receive FDA 510(k) clearance?

Pro-Tx Endorectal Balloon (PROT-25) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223249.

Who is the listed applicant for Pro-Tx Endorectal Balloon (PROT-25)?

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

What is the FDA product code for Pro-Tx Endorectal Balloon (PROT-25)?

The FDA product code for Pro-Tx Endorectal Balloon (PROT-25) is PCT.

Other records listing Dxtx Medical, 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.

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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.