# Stryker Instruments, Instruments Div.

- Location (FDA's records): Kalamazoo, MI
- FDA decisions: 6 (2007–2013): 6 510(k) clearances
- Product codes: NDN (2), FYA (2), GXI (1), BSO (1)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 14 (1 its own)
- Recalls linked to its devices: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- Stryker Instruments: 3 (https://510kreport.com/company/stryker-instruments)
- Cosman Medical, Inc.: 2 (https://510kreport.com/company/cosman-medical)
- Kyphon, Inc.: 2 (https://510kreport.com/company/kyphon)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)
- Vygon Corp.: 1 (https://510kreport.com/company/vygon)

## Firms that cite its devices most
- Stryker Corp.: 8 (https://510kreport.com/company/stryker)
- G21, S.R.L.: 2 (https://510kreport.com/company/g21)
- Lccs Products Limited: 1 (https://510kreport.com/company/lccs-products)
- Synthes: 1 (https://510kreport.com/company/synthes)
- Zavation, LLC: 1 (https://510kreport.com/company/zavation)

## Its most-cited devices
- K093419: Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas 3-10MM (8 Gauge)Balloon Catheter, Ivas (2010), cited by 8
- K113477: Ivas 20MM (10 Gauge) Balloon Catheter (2012), cited by 3
- K123178: Stryker Venom Electrodes and Cannulae (2013), cited by 2
- K073017: Stryker Stri-Shield Flyte Togas (2007), cited by 1

## Recent decisions
- K123178: Stryker Venom Electrodes and Cannulae (Mar 28, 2013)
- K113477: Ivas 20MM (10 Gauge) Balloon Catheter (Jan 6, 2012)
- K093419: Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas 3-10MM (8 Gauge)Balloon Catheter, Ivas (Mar 18, 2010)
- K072702: Stryker Antimic Catheter (Mar 19, 2008)
- K073017: Stryker Stri-Shield Flyte Togas (Nov 30, 2007)
- K070078: Stryker T4 Hytrel Toga (Feb 2, 2007)

Source page: https://510kreport.com/company/stryker-instruments-instruments-div