Surgitek Medical Engineering Corp. - FDA 510(k) Cleared Devices
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Surgitek Medical Engineering Corp. Gastroenterology & Urology ✕
10 devices
Cleared
Feb 18, 1992
CYTOLOGY BRUSH
Gastroenterology & Urology
132d
Cleared
Jan 30, 1992
E.R.C.P. CATHETER
Gastroenterology & Urology
114d
Cleared
Jan 03, 1992
BIOPSY FORCEPS
Gastroenterology & Urology
87d
Cleared
Dec 09, 1991
STONE BASKET
Gastroenterology & Urology
61d
Cleared
Dec 05, 1991
SCLEROTHERAPY NEEDLE
Gastroenterology & Urology
58d
Cleared
Dec 05, 1991
GRASPING FORCEPS
Gastroenterology & Urology
57d
Cleared
Nov 19, 1991
SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
Gastroenterology & Urology
77d
Cleared
Oct 04, 1991
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
Gastroenterology & Urology
72d
Cleared
Jun 25, 1991
SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
Gastroenterology & Urology
123d
Cleared
Mar 19, 1991
SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
Gastroenterology & Urology
25d