# Surgitek

- Location (FDA's records): Racine, WI
- FDA decisions: 29 (1983–1995): 29 510(k) clearances
- Product codes: FAD (9), LCJ (2), FGO (2), FAP (2), LKY (1), FBO (1), KNY (1), GEX (1), FFL (1), FGB (1), FEN (1), EYB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Acmi Corporation: 2 (https://510kreport.com/company/acmi)
- Circon Video: 1 (https://510kreport.com/company/circon-video)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Cabot Medical Corp.: 1 (https://510kreport.com/company/cabot-medical)

## Its most-cited devices
- K904797: Surgitek Graduated Cystoscope (Model GC-16) (1991), cited by 2
- K946296: Quadra-Coil Ureteral Stent (1995), cited by 1
- K920451: Endotek Ultra System (1992), cited by 1
- K930483: Ureteral Catheter (1993), cited by 1

## Recent decisions
- K946296: Quadra-Coil Ureteral Stent (Mar 6, 1995)
- K944391: OM-4 (Tenative) Urodynamic Measruement System (Feb 7, 1995)
- K943491: Right Angle Urologic Laser Fiber (Aug 5, 1994)
- K941952: Surgitek Infuser (May 24, 1994)
- K933260: Helical Stone/Flatwire Stone Baskets (Jan 11, 1994)
- K933261: Grasping Forceps (Jan 11, 1994)
- K930733: Ureteral Stent (Jul 23, 1993)
- K930483: Ureteral Catheter (Jul 16, 1993)

Source page: https://510kreport.com/company/surgitek