Medical Device Manufacturer · US , Mchenry , IL

Lake Region Mfg., Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1977

42

Total

42

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lake Region Mfg., Inc. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Aug 26, 2008

TAXI ENDOSCOPIC GUIDEWIRE

Gastroenterology & Urology · 70d

Cleared Jun 05, 1998

HYDROPHILIC COATED GUIDEWIRE

Gastroenterology & Urology · 25d

Cleared Mar 25, 1997

CORE AND COIL ASSEMBLY GUIDEWIRE

Gastroenterology & Urology · 6d

Cleared Apr 05, 1996

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND...

Gastroenterology & Urology · 32d

Cleared Sep 28, 1994

GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS

Gastroenterology & Urology · 336d

Cleared Sep 04, 1992

Gastroenterology & Urology · 176d

Cleared May 15, 1986

DUTHOY STONE BASKET

Gastroenterology & Urology · 23d