NEUROTHERM RF CANNULA— 510(k) K994344
Substantially EquivalentRocket Medical Plc
FDA 510(k) clearance K994344 for NEUROTHERM RF CANNULA, Substantially Equivalent on 2000-03-21. Applicant: Rocket Medical Plc. Device class: 2.
Clearance details
- Applicant
- Rocket Medical Plc
- Product code
- Code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, Tyne & Wear, GB
Recent devices under product code GXI
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view all- K210509 — Rocket Platinum Cured Cathter
- K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
- K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
- K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
- K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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.