Uresil, LLC

Skokie, IL, US

URESIL, LLC appears in FDA device records in Skokie, IL. FDA records list 49 510(k) clearances between 1981-10-02 and 2010-02-23, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 49
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 49 510(k) clearances for Uresil, LLC between 1981 and 2010. The busiest year on record is 1986, with 9. The most recent is 2010, with 1.

Clearances by year, as a table

510(k) clearance decisions for Uresil, LLC, by decision year
Year	Clearances
1981	1
1986	9
1987	6
1988	1
1990	3
1991	2
1992	6
1993	4
1994	3
1995	3
1997	2
1998	4
2001	1
2002	1
2004	1
2005	1
2010	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K093653	URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK	KNT	Unknown	2010-02-23
K053245	GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER	FGE	Substantially Equivalent	2005-12-20
K041995	MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY	GBO	Substantially Equivalent	2004-08-19
K021632	GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C	GBO	Substantially Equivalent	2002-06-13
K003753	GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE	FGE	Substantially Equivalent	2001-01-04
K980278	URESIL VASCU-FLO INFUSION CATHETER	DQY	Substantially Equivalent	1998-11-20
K981344	URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING	LJE	Substantially Equivalent	1998-09-10
K980282	URESIL DILATOR WITH RADIOPAQUE MARKER	DRE	Substantially Equivalent	1998-04-24
K980889	URESIL NEPHRO-URETERAL STENT	LJE	Substantially Equivalent	1998-04-08
K972582	URESIL GUIDEWIRE	FGE	Substantially Equivalent	1997-11-21
K972583	URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S	FGE	Substantially Equivalent	1997-08-29
K953923	URESIL INTRODUCING NEEDLE	KNW	Substantially Equivalent	1995-09-08
K945934	URESIL(R) GUIDEWIRE	DQX	Substantially Equivalent	1995-07-10
K942688	NEPHRO-URETERAL STENT	LJE	Substantially Equivalent	1995-06-06
K944784	MINI-OP LAPAROSCOPIC LASSO	GEI	Substantially Equivalent	1994-10-28
K942191	URESIL DILATOR	DYB	Substantially Equivalent	1994-09-21
K940505	ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)	HET	Substantially Equivalent	1994-06-21
K921417	URESIL LAPAROSCOPIC RETRACTOR	HET	Substantially Equivalent	1993-10-08
K925117	URESIL ABSCESS DRIANAGE AND IRRIGATION SET	GBX	Substantially Equivalent	1993-08-11
K923096	URESIL BILLIARY CATHETER	FGE	Substantially Equivalent	1993-07-13
K930011	URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS	MGZ	Substantially Equivalent	1993-05-26
K923219	URESIL SPECIMEN RETRIEVAL BAG	GCJ	Substantially Equivalent	1992-12-15
K923097	URESIL NEPHROSTOMY CATHETER	LJE	Substantially Equivalent	1992-09-14
K920510	URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER	GAR	Substantially Equivalent	1992-09-14
K920509	URESIL SUMP DRAINAGE CATHETER	LJE	Substantially Equivalent	1992-09-14
K915343	URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER	GCA	Substantially Equivalent	1992-03-31
K914699	URESIL FIXATION DEVICE	FGE	Substantially Equivalent	1992-02-19
K912109	URESIL GENERAL PURPOSE DRAINAGE CATHETER	GBO	Substantially Equivalent	1991-08-12
K905528	URESIL VALVE CUTTER	DWQ	Substantially Equivalent	1991-04-18
K903449	URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET	EXF	Substantially Equivalent	1990-09-12
K901882	URESIL ENDOSCOPIC LASER OVERTUBE	KOQ	Substantially Equivalent	1990-07-27
K901844	URESIL TRU-CLOSE DRAINAGE BAG	EXF	Substantially Equivalent	1990-06-01
K880895	URESIL WOUND DRAIN TROCAR	GBS	Substantially Equivalent	1988-03-14
K872948	URESIL THORA-FLO THORACENTESIS PROCEDURE KIT	JOL	Unknown	1987-11-27
K872788	MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN	DWF	Substantially Equivalent	1987-09-25
K871148	URESIL CAROTID ARTERY SIZERS	DRE	Substantially Equivalent	1987-04-22
K870141	URESIL T-SYSTEM BONE SCREWS	HWC	Substantially Equivalent	1987-02-03
K863684	URESIL SUBCLAVIAN CATHETER	DQY	Substantially Equivalent	1987-01-06
K864007	EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER	DXE	Substantially Equivalent	1987-01-02
K863558	URESIL CAROTID SHUNT	DWF	Substantially Equivalent	1986-11-24
K863571	BILIARY BALLOON CATHETER	FGE	Substantially Equivalent	1986-11-04
K863564	URESIL IRRIGATION CATHETER	DQY	Substantially Equivalent	1986-10-10
K863559	URESIL OCCLUSION BALLOON CATHETER	DQT	Substantially Equivalent	1986-10-10
K863563	URESIL RADIOPAQUE SILICONE BANDS		Substantially Equivalent	1986-10-02
K863562	URESIL 150CC BELLOWS RESERVOIR	GCY	Substantially Equivalent	1986-09-29
K863560	URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA	GBS	Substantially Equivalent	1986-09-29
K863561	URESIL THORACIC VENT	KDQ	Substantially Equivalent	1986-09-23
K863505	URESIL CLOSED DRAINAGE RESERVOIR	GCY	Substantially Equivalent	1986-09-18
K812640	URE SIL EMBOLECTOMY/THROMBECTOMY CATH	DXE	Substantially Equivalent	1981-10-02

Registered establishments

FDA registered establishments for Uresil, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1450395	1450395	URESIL, LLC	5418 WEST TOUHY AVE., SKOKIE, IL 60077 US	2026	EXF FGE GBO GCY KDQ KGX KGZ LJE

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain