FDA 510(k)

RectalPro 75 Endorectal Balloon

K-Number: K180478 · 2018-11-13

Decision Date2018-11-13

Product CodePCT

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RectalPro 75 Endorectal Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Qlrad International , Ltd.. It received FDA 510(k) clearance on 2018-11-13 under 510(k) 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. The listed applicant is Qlrad International , Ltd.. The 510(k) number is K180478.

When did RectalPro 75 Endorectal Balloon receive FDA 510(k) clearance?

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

Who is the listed applicant for RectalPro 75 Endorectal Balloon?

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

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)

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.

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

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.