LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE— 510(k) K002765
Substantially EquivalentIntegra Neurosciences
FDA 510(k) clearance K002765 for LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE, Substantially Equivalent on 2000-11-24. Applicant: Integra Neurosciences. Device class: 2.
Clearance details
- Applicant
- Integra Neurosciences
- 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
- San Diego, CA, US
Recent devices under product code GWM
view allMore clearances from Integra Neurosciences
view all- K082250 — AURAGEN CORTICAL SURFACE ELECTRODES
- K050720 — NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
- K031086 — CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
- K021989 — SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
- K022554 — MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
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 K002765
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 K002765.
Data sourced from openFDA. This site is unofficial and independent of the FDA.