Medical Engineering Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 28
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | November 18, 1993 |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | March 13, 1991 |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | January 14, 1991 |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | July 16, 1990 |
| K884746 | SURGITEK FLAT T-SPAN | August 10, 1989 |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | February 8, 1989 |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | August 11, 1988 |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | May 26, 1988 |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | May 26, 1988 |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | September 26, 1984 |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | October 20, 1983 |
| K833008 | PERCUTANEOUS NEPHROSTOMY CATHETER | October 19, 1983 |
| K831857 | SURGITEK PERCUTANEOUS ARNEGRADE SILITEK | August 11, 1983 |
| K830884 | SURGITEKS PERCUTANEOUS ANTEGRADE ALL - | May 9, 1983 |
| K823757 | SURGITEK ENDOTRACHEAL TUBE, LASER RESIS | April 28, 1983 |
| K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS | April 12, 1983 |
| K830226 | SURGITEK PERCUTANEOUS NEPHROSTOMY CATH | February 9, 1983 |
| K822295 | SURGI TEK'S DISPOS. INNER CANNULA FOR | August 20, 1982 |
| K821776 | SURGITEK PERCUTANEOUS NEPHROST. STENT | August 10, 1982 |
| K803156 | SURGITEK MEDI-LOOPS | January 15, 1981 |