CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)— 510(k) K232890
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K232890 for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845), Substantially Equivalent on 2024-02-04. Applicant: Integra Lifesciences Production Corporation. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Production Corporation
- Product code
- Code GWM
- Device class
- Class 2
- Regulation
- 21 CFR 882.1620
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code GWM
view allMore clearances from Integra Lifesciences Production Corporation
view all- K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more
- 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
- K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
- K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
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 →
Recalls naming K232890
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232890.
Data sourced from openFDA. This site is unofficial and independent of the FDA.