Codman EDS3 CSF External Drainage System— 510(k) K162437
Substantially EquivalentCodman & Shurtleff, Inc.
FDA 510(k) clearance K162437 for Codman EDS3 CSF External Drainage System, Substantially Equivalent on 2016-10-28. 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
view allMore clearances from Codman & Shurtleff, Inc.
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
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
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 →
Recalls naming K162437
K-number listed on FDA's recall record- Z-0634-2024 — External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
- Z-0635-2024 — EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
- Z-1143-2021 — Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162437.
Data sourced from openFDA. This site is unofficial and independent of the FDA.