Optyx
FDA 510(k) K904883 · Baxter Healthcare Corp
510(k) numberK904883
Submission
- Device name
- Optyx
- Applicant
- Baxter Healthcare Corp
Irvine, CA, US - Received
- October 26, 1990
- Decision date
- July 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
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| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
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| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
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Questions and answers
When was Optyx cleared by the FDA?
Optyx (K904883) received a 510(k) decision of Substantially Equivalent on July 24, 1991, 271 days after the submission was received.
What is the product code of K904883?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.