Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RectalPro 75 Endorectal Balloon

K-Number: K180478 · 2018-11-13

ApplicantQlrad International , Ltd.
Decision Date2018-11-13
Product CodePCT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RectalPro 75 Endorectal Balloon is a medical device manufactured by Qlrad International , Ltd.. It received FDA 510(k) clearance on 2018-11-13 under approval number K180478. 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 RectalPro 75 Endorectal Balloon?

RectalPro 75 Endorectal Balloon is a medical device that received FDA 510(k) clearance on 2018-11-13. It is manufactured by Qlrad International , Ltd.. The 510(k) number is K180478.

When was RectalPro 75 Endorectal Balloon approved by the FDA?

RectalPro 75 Endorectal Balloon received FDA 510(k) clearance on 2018-11-13, under approval number K180478.

What company makes RectalPro 75 Endorectal Balloon?

RectalPro 75 Endorectal Balloon is manufactured by Qlrad International , Ltd..

What is the FDA product code for RectalPro 75 Endorectal Balloon?

The FDA product code for RectalPro 75 Endorectal Balloon is PCT.

Related Devices (Code: PCT)

K223249Pro-Tx Endorectal Balloon (PROT-25)Dxtx Medical, Inc.

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.

↑