Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory— 510(k) K152897
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K152897 for Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory, Substantially Equivalent on 2016-03-04. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- 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
- Planisboro, NJ, US
Recent devices under product code JXG
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- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
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.