OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation Syst
Summary
Stryker Instruments received 510(k) clearance for OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit), a GXI device. Cleared on 2025-05-15.
Details
Source
510(k) Clearance
External ID
K250213
Action Date
2025-05-15
Status
Traditional
Category
device
Product Code
GXI
Product Description
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit). Product code: GXI.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Stryker Instruments has received 15 total clearances in our database.
Stryker Instruments has 16 FDA actions in our database, including 1 recall and 15 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Stryker Instruments have FDA actions?
Stryker Instruments has 16 FDA actions in our database, including 1 recall and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250213" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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