Medical Device Manufacturer · US , Mchenry , IL

Surgitek - FDA 510(k) Cleared Devices

29 submissions · 28 cleared · Since 1983

Recent clearances: QUADRA-COIL URETERAL STENT, OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM, RIGHT ANGLE UROLOGIC LASER FIBER

29

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Surgitek General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Aug 05, 1994

RIGHT ANGLE UROLOGIC LASER FIBER

General & Plastic Surgery · 17d

Cleared Sep 05, 1990

SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER

General & Plastic Surgery · 103d

Cleared Jan 17, 1990

SURGITEK(R) EXTERNAL FILL PORT

General & Plastic Surgery · 182d

Cleared Mar 12, 1984

TISSUE EXPANDER

General & Plastic Surgery · 38d