CereLink ICP Monitor— 510(k) K210993
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K210993 for CereLink ICP Monitor, Substantially Equivalent on 2021-04-30. 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
- Special
- 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 K210993
K-number listed on FDA's recall record- Z-0548-2024 — CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
- Z-1395-2022 — CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210993.
Data sourced from openFDA. This site is unofficial and independent of the FDA.