Medical Device Manufacturer · US , Mchenry , IL

Mill-Rose Laboratory - FDA 510(k) Cleared Devices

46 submissions · 44 cleared · Since 1979
46
Total
44
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mill-Rose Laboratory Gastroenterology & Urology
20 devices
1-20 of 20
Cleared May 23, 1997
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · FDI
Gastroenterology & Urology · 46d
Cleared Dec 22, 1995
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · FBK
Gastroenterology & Urology · 85d
Cleared Dec 18, 1995
MILL-ROSE ROTATABLE POLYPECTOMY SNARE
K951600 · FDI
Gastroenterology & Urology · 255d
Cleared Mar 15, 1995
RITE-BITE BIOPSY FORCEPS
K951048 · FCL
Gastroenterology & Urology · 9d
Cleared Feb 16, 1995
MILL-ROSE SCOPE CLEANING BRUSH
K946293 · MNL
Gastroenterology & Urology · 51d
Cleared Feb 16, 1995
DIENER RETRIEVAL DEVICES
K950559 · FCL
Gastroenterology & Urology · 8d
Cleared Jul 12, 1994
WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
K942630 · KNW
Gastroenterology & Urology · 39d
Cleared May 06, 1994
E-Z PEG
K921680 · KNT
Gastroenterology & Urology · 758d
Cleared Feb 08, 1993
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
K921800 · FBK
Gastroenterology & Urology · 300d
Cleared Feb 09, 1990
SUCTION BIOPSY INSTRUMENT
K895420 · FCK
Gastroenterology & Urology · 161d
Cleared Mar 17, 1989
COLONOSCOPE GUIDING TUBE DEVICE
K884857 · FDF
Gastroenterology & Urology · 116d
Cleared Apr 22, 1985
ENDOSOPIC STENE MANIPULATING BALLOON
K850489 · LQR
Gastroenterology & Urology · 73d
Cleared Oct 02, 1984
ESOPHAGEAL DILATOR SET
K842679 · FAT
Gastroenterology & Urology · 84d
Cleared Oct 31, 1983
ENDOSCOPIC OVERTUBE
K833268 · FED
Gastroenterology & Urology · 40d
Cleared Apr 16, 1982
ENDOSCOPIC INJECTION NEEDLE
K820973 · FBK
Gastroenterology & Urology · 10d
Cleared Oct 23, 1980
E.R.C.P. CANNULA PRODUCT
K802443 · ODD
Gastroenterology & Urology · 16d
Cleared Oct 23, 1980
PAPILLOTOME PRODUCT
K802444 · KNS
Gastroenterology & Urology · 16d
Cleared Dec 20, 1979
STONE AND RETRIEVAL BASKET
K792344 · FFL
Gastroenterology & Urology · 31d
Cleared Dec 20, 1979
RETRIEVABLE FORCEPS
K792345 · OCZ
Gastroenterology & Urology · 31d
Cleared Oct 01, 1979
ENDOSCOPIC CYTOLOGY BRUSHES
K791668 · FDX
Gastroenterology & Urology · 34d
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