PatCom Single-Use Introducer
K-Number: K192691 · 2020-02-21
ApplicantH&A Mui Enterprises, Inc.
Decision Date2020-02-21
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PatCom Single-Use Introducer is a medical device manufactured by H&A Mui Enterprises, Inc.. It received FDA 510(k) clearance on 2020-02-21 under approval number K192691. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PatCom Single-Use Introducer?
PatCom Single-Use Introducer is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by H&A Mui Enterprises, Inc.. The 510(k) number is K192691.
When was PatCom Single-Use Introducer approved by the FDA?
PatCom Single-Use Introducer received FDA 510(k) clearance on 2020-02-21, under approval number K192691.
What company makes PatCom Single-Use Introducer?
PatCom Single-Use Introducer is manufactured by H&A Mui Enterprises, Inc..
What is the FDA product code for PatCom Single-Use Introducer?
The FDA product code for PatCom Single-Use Introducer is FED.
Other Devices by H&A Mui Enterprises, Inc.
Related Devices (Code: FED)
K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.
K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.
K160846AmplifEYEMedivators, Inc.
K160861Proxis Ureteral Access SheathC.R. Bard, Inc.
K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd.
K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated
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.