Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag— 510(k) K172537
Substantially EquivalentCodman & Shurtleff, Inc.
FDA 510(k) clearance K172537 for Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag, Substantially Equivalent on 2017-10-16. Applicant: Codman & Shurtleff, Inc.. Device class: 2.
Clearance details
- Applicant
- Codman & Shurtleff, Inc.
- 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
- Raynham, MA, US
Recent devices under product code JXG
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view all- K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
- K191237 — CERENOVUS Large Bore Catheter
- K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
- K171862 — GALAXY G3 Mini Microcoil Delivery 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.