# Milex Products, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 8 (1976–2000): 8 510(k) clearances
- Product codes: HHW (2), HHK (2), KNA (1), HHT (1), GDF (1), HIR (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Senorx, Inc.: 1 (https://510kreport.com/company/senorx)
- Imagyn Medical Technologies, Inc.: 1 (https://510kreport.com/company/imagyn-medical-technologies)
- Mentor Corp.: 1 (https://510kreport.com/company/mentor)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)

## Its most-cited devices
- K861385: Milex Bartholin Gland Catheter (1986), cited by 1
- K904026: Inflat-O-Ball (1990), cited by 1
- K900903: Kopans Hookwire Lesion Localization Needle (1990), cited by 1
- K760264: Curette, Proposed Tis-U-Trap, Metal (1976), cited by 1

## Recent decisions
- K001545: Pipet Curet (Jun 15, 2000)
- K904774: Inglat-O-Ball (Dec 7, 1990)
- K904026: Inflat-O-Ball (Oct 10, 1990)
- K900903: Kopans Hookwire Lesion Localization Needle (May 3, 1990)
- K882628: Endo C Brush (Jul 25, 1988)
- K862410: Milex Kegel Perineal Exerciser (Jul 31, 1986)
- K861385: Milex Bartholin Gland Catheter (Jun 16, 1986)
- K760264: Curette, Proposed Tis-U-Trap, Metal (Oct 6, 1976)

Source page: https://510kreport.com/company/milex-products