Data / Medical devices / United States / Uramix, Inc.

Uramix, Inc.: FDA-registered device maker in E Lansdowne, PA, United States, 4 510(k) clearances

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

Uramix, Inc. is registered with the FDA (registration 2531475) in E Lansdowne, PA, United States. It lists 18 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 10, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2531475
FEI number: 3001642379
Address: 272 N. Lansdowne Ave., E Lansdowne, PA, United States, 19050
Owner or operator: URAMIX, INC. (9032397)
Roles: Repackager or relabeler, Specification developer
First device listed: December 8, 1997
Registered through: 2027
Brand names listed: Corpus Ruler, Corpus Ruler-Dilator, Double-Bladed Advanced Cavernotome (DBAC), Easy-Jet Irrigator, Figure "8" Disposable Retractor, Instrument Tray, Mooreville Penile Dilator, Mooreville Urethrotome and more

Devices it lists

Device	Product code	Class	Role	Source
Clamp, Non-Electrical	FFN	1	Repackager or relabeler	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Repackager or relabeler	accessdata.fda.gov
Goniometer, Nonpowered	KQW	1	Specification developer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Repackager or relabeler	accessdata.fda.gov
Needle, Gastro-Urology	FHR	1	Specification developer	accessdata.fda.gov
Penile Implant Surgical Accessories	QGA	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Specification developer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Suprapubic Catheter Accessories	QGC	1	Repackager or relabeler	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Specification developer	accessdata.fda.gov
System, Evacuator, Fluid	FHF	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	accessdata.fda.gov
Tray, Biopsy, Without Biopsy Instruments	FCH	1	Specification developer	accessdata.fda.gov
Ureteral Stent Accessories	QGB	1	Repackager or relabeler	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Repackager or relabeler	accessdata.fda.gov
Urethrotome	EZO	2	Specification developer	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
May 10, 2024	K240374	Ureterorenoscope System	FGB	Substantially Equivalent	Shenzhen HugeMed Medical Technical Development Co., Ltd.	accessdata.fda.gov
November 13, 2023	K231118	Cystoscope System	FAJ	Substantially Equivalent	Shenzhen HugeMed Medical Technical Development Co., Ltd.	accessdata.fda.gov
July 7, 2023	K223448	Bladder Scanner Model: BVT02	IYO	Substantially Equivalent	Xuzhou Kaixin Electronic Instrument Co., Ltd.	accessdata.fda.gov
September 17, 2021	K203141	Uramix CuraWay Biopsy Needle	KNW	Substantially Equivalent	Uramix, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 10, 2024. 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.