# O.R. Concepts, Inc.

- Location (FDA's records): Roanoke, TX
- FDA decisions: 34 (1986–1994): 34 510(k) clearances
- Product codes: GCJ (9), GEI (7), GCY (2), KKX (2), KME (1), GCI (1), FGS (1), MDM (1), HIG (1), KGX (1), GBZ (1), HIF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Batrik Medical Manufacturing, Inc.: 1 (https://510kreport.com/company/batrik-medical-manufacturing)
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler: 1 (https://510kreport.com/company/turkuaz-saglik-hizmetleri-medikal-temizlik-kimyasal-urunler)

## Its most-cited devices
- K932449: DR. FOG (1993), cited by 2

## Recent decisions
- K941337: Flowgun Electrocautery Probes (Aug 17, 1994)
- K935970: Flowgun Electrocautery Probe Handle (May 16, 1994)
- K935971: Flowgun Electrocautery Probes (May 16, 1994)
- K935645: Flowgun Reusable Irrigation Probes (Mar 7, 1994)
- K926242: Orc Endoscopic Monopolar Electrosurgical Probe (Oct 15, 1993)
- K922197: Insufflator Tubing Kit (Sep 24, 1993)
- K922244: Insufflator Tubing/Filter Kit (Sep 24, 1993)
- K932449: DR. FOG (Aug 11, 1993)

Source page: https://510kreport.com/company/or-concepts