Medical Engineering Corp. - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medical Engineering Corp. Gastroenterology & Urology ✕
16 devices
Cleared
Nov 18, 1993
STAND ALONE CYSTOMETROGRAM
Gastroenterology & Urology
85d
Cleared
Mar 13, 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
Gastroenterology & Urology
107d
Cleared
Jul 16, 1990
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
Gastroenterology & Urology
21d
Cleared
Feb 08, 1989
SURGITEK (R) UROFLOW SYSTEM
Gastroenterology & Urology
189d
Cleared
Aug 11, 1988
SURGITEK CO2 DELIVERY SYSTEM
Gastroenterology & Urology
111d
Cleared
May 26, 1988
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
Gastroenterology & Urology
87d
Cleared
May 26, 1988
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
Gastroenterology & Urology
87d
Cleared
Oct 20, 1983
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
Gastroenterology & Urology
118d
Cleared
Oct 19, 1983
PERCUTANEOUS NEPHROSTOMY CATHETER
Gastroenterology & Urology
43d
Cleared
Aug 11, 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
Gastroenterology & Urology
63d
Cleared
May 09, 1983
SURGITEKS PERCUTANEOUS ANTEGRADE ALL -
Gastroenterology & Urology
49d
Cleared
Apr 12, 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
Gastroenterology & Urology
21d
Cleared
Feb 09, 1983
SURGITEK PERCUTANEOUS NEPHROSTOMY CATH
Gastroenterology & Urology
16d
Cleared
Aug 10, 1982
SURGITEK PERCUTANEOUS NEPHROST. STENT
Gastroenterology & Urology
54d
Cleared
Feb 26, 1980
SURGITEK URINARY DIVERSION STENT
Gastroenterology & Urology
41d
Cleared
Dec 07, 1978
SURGITEK DOUBLE J URETEROL STENT
Gastroenterology & Urology
77d