Intellidrop— 510(k) K251598
Substantially EquivalentBrainspace, Inc.
FDA 510(k) clearance K251598 for Intellidrop, Substantially Equivalent on 2025-12-10. Applicant: Brainspace, Inc.. Device class: 2.
Clearance details
- Applicant
- Brainspace, Inc.
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code JXG
view all- K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more
- K250636 — Sophy Mini Monopressure Valve (SM1)
- K252514 — EVAC-MRI
- K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
- K243552 — Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761) +1 more
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.