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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is H&A Mui Enterprises, Inc.. It received FDA 510(k) clearance on 2020-02-21 under 510(k) 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. The listed applicant is H&A Mui Enterprises, Inc.. The 510(k) number is K192691.

When did PatCom Single-Use Introducer receive FDA 510(k) clearance?

PatCom Single-Use Introducer received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192691.

Who is the listed applicant for PatCom Single-Use Introducer?

The FDA 510(k) record lists H&A Mui Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PatCom Single-Use Introducer?

The FDA product code for PatCom Single-Use Introducer is FED.

Other records listing H&A Mui Enterprises, 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.

K222587PatCom Distal Chip Endoscope

Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.

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.

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