Data / Medical devices / Canada / Mui Scientific

Mui Scientific: FDA-registered device maker in MISSISSAUGA Ontario, Canada, 8 510(k) clearances

Name: Mui Scientific FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mui Scientific is registered with the FDA (registration 9611668) in MISSISSAUGA Ontario, Canada. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 28, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9611668
FEI number: 3002807135
Address: 145 Traders BLVD. East, # 34, MISSISSAUGA Ontario, Canada, L4Z 3L3
Owner or operator: H & A MUI ENTERPRISES INC. (8020404)
Roles: Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: December 11, 2007
Registered through: 2026
Brand names listed: Anorectal Balloon Expulsion Catheters, Anorectal Catheters, Barostat / Motility Catheters, Barostat Catheters, Colonic Catheters, Dentsleeve Catheter, Esophageal Barostat Catheters, Esophageal Catheters and more

Devices it lists

Device	Product code	Class	Role	Source
Camera, Television, Endoscopic, Without Audio	FWF	1	Exporter to the US	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Manufacturer	accessdata.fda.gov
Monitor, Esophageal Motility, Anorectal Motility, And Tube	KLA	2	Manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
System, Gastrointestinal Motility (Electrical)	FFX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 28, 2023	K222587	PatCom Distal Chip Endoscope	EOB	Substantially Equivalent	H&A Mui Enterprises, Inc.	accessdata.fda.gov
February 21, 2020	K192691	PatCom Single-Use Introducer	FED	Substantially Equivalent	H&A Mui Enterprises, Inc.	accessdata.fda.gov
March 14, 2017	K160287	Rapid Barostat Bag (RBB) Pump and Catheter	FFX	Substantially Equivalent	Mui Scientific	accessdata.fda.gov
November 1, 2012	K122294	PRESSURIZED INFUSION PUMP	FFX	Substantially Equivalent	Mui Scientific	accessdata.fda.gov
June 21, 2012	K120524	SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM	FFX	Substantially Equivalent	Mui Scientific	accessdata.fda.gov
June 4, 1999	K973844	GASTRIC AND RECTAL CATHETERS	FFX	Substantially Equivalent	G & J Electronics, Inc.	accessdata.fda.gov
May 17, 1999	K983665	MANOMETRIC ASSEMBLIES	KLA	Substantially Equivalent	Dentsleeve Pty., Ltd.	accessdata.fda.gov
February 15, 1983	K823701	MOTILITY CATHETERS	FFX	Substantially Equivalent	Mui Scientific	accessdata.fda.gov

Compare with other makers

Updated July 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.