Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable— 510(k) K182801
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K182801 for Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable, Substantially Equivalent on 2018-11-27. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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More clearances from Integra LifeSciences Corporation
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- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.