Surgitek Medical Engineering Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K914504 | CYTOLOGY BRUSH | February 18, 1992 |
| K914495 | E.R.C.P. CATHETER | January 30, 1992 |
| K914497 | BIOPSY FORCEPS | January 3, 1992 |
| K914505 | STONE BASKET | December 9, 1991 |
| K914503 | GRASPING FORCEPS | December 5, 1991 |
| K914496 | SCLEROTHERAPY NEEDLE | December 5, 1991 |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | November 19, 1991 |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | October 4, 1991 |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | June 25, 1991 |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | March 19, 1991 |
| K903127 | SURGITEK(R) TURP MONITOR | October 9, 1990 |