Codman Certas Plus Electronic Tool Kit— 510(k) K181902
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K181902 for Codman Certas Plus Electronic Tool Kit, Substantially Equivalent on 2018-10-25. Applicant: Integra Lifesciences Corp.. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Corp.
- 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
- Mansfield, MA, US
Recent devices under product code JXG
view allMore clearances from Integra Lifesciences Corp.
view all- K183581 — Codman Disposable Perforators
- K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable
- K182265 — CodMan Certas Plus Programmable Valve
- K150682 — CUSA Excel+
- K150428 — Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
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.