# Apogee, Inc.

- Location (FDA's records): Raleigh, NC
- FDA decisions: 2 (1995–1999): 2 510(k) clearances
- Product codes: GBM (1), DXT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Robling Medical: 1 (https://510kreport.com/company/robling-medical)

## Its most-cited devices
- K992137: Urological Catheter (1999), cited by 1

## Recent decisions
- K992137: Urological Catheter (Sep 3, 1999)
- K942381: Low Pressure Injection Tubing, Coiled Line, Extension Tubing (Mar 17, 1995)

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