# Urohealth Systems, Inc.

- Location (FDA's records): Richland, MI
- FDA decisions: 3 (1997–1998): 3 510(k) clearances
- Product codes: GEI (1), GDW (1), EOQ (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: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Novare Surgical Systems, Inc.: 1 (https://510kreport.com/company/novare-surgical-systems)

## Its most-cited devices
- K972510: Pivotal Scissor (1997), cited by 1

## Recent decisions
- K980617: Modification to Reflex Aec Linear Stapler/Cutter (Apr 9, 1998)
- K970107: Intubation Endoscope and Introducer Sheath (Nov 18, 1997)
- K972510: Pivotal Scissor (Nov 13, 1997)

Source page: https://510kreport.com/company/urohealth-systems