Pro-Tx Endorectal Balloon (PROT-25)
K-Number: K223249 · 2023-02-10
ApplicantDxtx Medical, Inc.
Decision Date2023-02-10
Product CodePCT
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Pro-Tx Endorectal Balloon (PROT-25) is a medical device manufactured by Dxtx Medical, Inc.. It received FDA 510(k) clearance on 2023-02-10 under approval 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. It is manufactured by Dxtx Medical, Inc.. The 510(k) number is K223249.
When was Pro-Tx Endorectal Balloon (PROT-25) approved by the FDA?
Pro-Tx Endorectal Balloon (PROT-25) received FDA 510(k) clearance on 2023-02-10, under approval number K223249.
What company makes Pro-Tx Endorectal Balloon (PROT-25)?
Pro-Tx Endorectal Balloon (PROT-25) is manufactured by Dxtx Medical, Inc..
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 Devices by Dxtx Medical, Inc.
Related Devices (Code: PCT)
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.