# Wiltek Medical, Inc.

- Location (FDA's records): Winston-Salem, NC
- FDA decisions: 21 (1989–1999): 21 510(k) clearances
- Product codes: FGE (6), GEI (3), LQR (2), FDX (1), BSS (1), OCZ (1), FPD (1), BYY (1), KGE (1), BWH (1), FBK (1), KNS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (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
- Bard Interventional Products Div.: 2 (https://510kreport.com/company/bard-interventional-products-div)
- Ballard Medical Products: 1 (https://510kreport.com/company/ballard-medical-products)

## Its most-cited devices
- K894861: Wiltek Papillotome (1989), cited by 3

## Recent decisions
- K990231: Wiltek Hot Biopsy Forceps (Apr 13, 1999)
- K922989: Wiltek Irrigaiton/Aspiration Tube Set (Feb 15, 1994)
- K930419: Wiltek Biopsy Forceps (Jun 1, 1993)
- K914882: Wiltek Balloon Cholangiography Catheter (Jan 7, 1992)
- K914881: Wiltek Laparoscopic Cholangiography Catheter (Jan 7, 1992)
- K914131: Wiltek Electrocautery Adaptor (Sep 25, 1991)
- K914132: Wiltek Electrocautery Active Cord (Sep 25, 1991)
- K912288: Wiltek Standard Cholangiography Catheter (Sep 23, 1991)

Source page: https://510kreport.com/company/wiltek-medical