Spetzler Lumbar-Peritoneal System
FDA 510(k) K811288 · American Heyer Schulte
510(k) numberK811288
Submission
- Device name
- Spetzler Lumbar-Peritoneal System
- Applicant
- American Heyer Schulte
Mchenry, IL, US - Received
- May 11, 1981
- Decision date
- June 26, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional | Integra Lifesciences Production Corporation | 06/23/2026SE |
| K251598 | IntellidropJXG · Traditional | Brainspace, Inc. | 12/10/2025SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
| K252514 | Evac-MriJXG · Traditional | Phasor Health, LLC | 11/05/2025SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional | Integra Lifesciences Production Corporation | 08/08/2025SE |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | Sophysa | 06/20/2025SE |
| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840172 | Ventral Wall Defect Reduct SiloFTL · Traditional | 06/27/1984SE |
| K834593 | One-Piece ShuntJXG · Traditional | 04/03/1984SE |
| K833502 | Radovan Subcutaneous Tissue ExpanderLCJ · Traditional | 02/03/1984SE |
| K833698 | Amer. V. Mueller Surg. Staples IlaGDW · Traditional | 01/25/1984SE |
| K833704 | Amer. V. Mueller Surgicalstaples-CartrGDW · Traditional | 12/29/1983SE |
| K832738 | Heyer-Schulte Afterloading CatheterIWJ · Traditional | 09/29/1983SE |
| K823790 | Ventricular Access SystemLKG · Traditional | 04/28/1983SE |
| K822096 | Chemotherapy Infusion CatheterJCY · Traditional | 04/12/1983SE |
| K822032 | Large Volume Closed Wound Suction DrainGCY · Traditional | 08/16/1982SE |
| K820247 | External Ventricular Drainage Sys.JXG · Traditional | 02/18/1982SE |
Questions and answers
When was Spetzler Lumbar-Peritoneal System cleared by the FDA?
Spetzler Lumbar-Peritoneal System (K811288) received a 510(k) decision of Substantially Equivalent on June 26, 1981, 46 days after the submission was received.
What is the product code of K811288?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.