Data / Medical devices / United States / Greystone Medical, LLC

Greystone Medical, LLC: FDA-registered device maker in Waterford, MI, United States, 10 510(k) clearances

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

Greystone Medical, LLC is registered with the FDA (registration 3015176887) in Waterford, MI, United States. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 2, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015176887
Address: 7433 Pine Creek Trail Suite#B, Waterford, MI, United States, 48327
Owner or operator: Greystone Medical, LLC (10058460)
Roles: Specification developer
First device listed: January 20, 2019
Registered through: 2026
Brand names listed: ALCOHOL PAD /ALCOHOL PREP PAD, GREYSTONE 1ML INJECTION CONVENIENCE NEEDLE PACK, GREYSTONE 3ML INJECTION CONVENIENCE NEEDLE PACK, GREYSTONE HYDROPHILIC URETHRAL CATHETER- JAW [Just Add Water] with or without attached drainage Bag, Greystone Medical -BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE, Greystone Medical -CATHETER 2-Way, RETENTION TYPE, BALLOON, Greystone Medical -CATHETER STABILIZATION DEVICE, CATHETER SECUREMENT, Greystone Medical -CATHETER, STRAIGHT Intermittent/Coude and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Urine Collection, Leg, For External Use, Non-Sterile	NNW	1	Specification developer	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Specification developer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Specification developer	accessdata.fda.gov
Catheter, Straight	EZD	2	Specification developer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Specification developer	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Specification developer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Specification developer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Specification developer	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Specification developer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Specification developer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Specification developer	accessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	FCM	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
July 2, 2021	K202570	Insulin Syringe, Insulin Syringe with Safety Retractable	MEG	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.	accessdata.fda.gov
September 6, 2019	K183665	Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use	MEG	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.	accessdata.fda.gov
October 28, 2014	K142563	Well Lead PVC Urethral Catheter	EZD	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
February 24, 2014	K133615	WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER	EZD	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
October 3, 2013	K130908	DISPOSABLE SILICONE FOLEY CATHETER	EZL	Substantially Equivalent	Guangdong Baihe Medical Technology Co., Ltd.	accessdata.fda.gov
April 10, 2012	K112110	STERILE LUBRICATING JELLY	KMJ	Substantially Equivalent	Jianerkang Medical Dressing Company	accessdata.fda.gov
February 13, 2012	K111405	BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,	GBM	Substantially Equivalent	Hangzhou Bever Medical Devices Co., Ltd.	accessdata.fda.gov
October 8, 2008	K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	EZL	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
May 23, 2003	K030712	AMSURE URETHRAL CATHETERIZATION TRAY	FCM	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
May 23, 2003	K030664	AMSURE FOLEY INSERTION TRAY	FCM	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 2, 2021. 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.