# Cook Urological, Inc.

- Location (FDA's records): Spencer, IN
- FDA decisions: 104 (1986–2011): 104 510(k) clearances
- Product codes: KOD (6), FAD (5), GEI (5), EZN (5), HET (5), MQL (5), GCJ (4), LJE (4), GEX (3), EZL (3), KNA (3), HHO (2)
- Predicates its devices cite: 41 (6 its own); citations of its devices by later devices: 70 (6 its own)
- Recalls linked to its devices: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 4 (https://510kreport.com/company/cr-bard)
- Applied Medical Resources: 3 (https://510kreport.com/company/applied-medical-resources)
- Vance Products, Inc.: 3 (https://510kreport.com/company/vance-products)
- Advanced Uroscience, Inc.: 2 (https://510kreport.com/company/advanced-uroscience)
- Cook Ob/Gyn: 2 (https://510kreport.com/company/cook-ob-gyn)
- Innovaquartz, LLC: 1 (https://510kreport.com/company/innovaquartz)
- Convergent Laser Technologies: 1 (https://510kreport.com/company/convergent-laser-technologies)
- Medical Engineering Corp.: 1 (https://510kreport.com/company/medical-engineering)

## Firms that cite its devices most
- Cook, Inc.: 18 (https://510kreport.com/company/cook)
- William A. Cook Australia Pty., Ltd.: 4 (https://510kreport.com/company/william-a-cook-australia)
- Applied Medical Resources: 3 (https://510kreport.com/company/applied-medical-resources)
- Cook Ireland, Ltd.: 3 (https://510kreport.com/company/cook-ireland)
- Coloplast Corp.: 2 (https://510kreport.com/company/coloplast)
- Rusch Intl.: 2 (https://510kreport.com/company/rusch-intl)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Crossbay Medical, Inc.: 2 (https://510kreport.com/company/crossbay-medical)

## Its most-cited devices
- K022484: Cook Injection Needle (2002), cited by 6
- K961904: AQ Hydrophilic Dilators (1996), cited by 5
- K961446: AQ Hydrophilic Stent (1996), cited by 3
- K970041: Ascend Balloon Dailation Catheter (1997), cited by 3
- K011157: Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit (2001), cited by 3
- K082066: Tao Brush I.U.M.C. Endometrial Sampler (2008), cited by 3

## Recent decisions
- K102141: Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined) (May 6, 2011)
- K091767: 3 Way Silicone Foley Balloon Catheter (Oct 9, 2009)
- K082939: Cook Fetal Membrane Manipulator, Model -FMM-122400 (Sep 3, 2009)
- K082066: Tao Brush I.U.M.C. Endometrial Sampler (Nov 7, 2008)
- K082536: Cook Wire Guides (Oct 27, 2008)
- K082319: Injekt Filiform Injection Needle (Sep 25, 2008)
- K080525: Cook Odyssey Holmium Laser System, Model 30W (Apr 17, 2008)
- K073496: Optilite Holmium Laser Fibers (Jan 23, 2008)

Source page: https://510kreport.com/company/cook-urological