# Medtronic PS Medical

- Location (FDA's records): Goleta, CA
- FDA decisions: 14 (1996–2002): 14 510(k) clearances
- Product codes: GWG (4), JXG (4), GXR (1), GEI (1), HCA (1), LIS (1), LJS (1), GWM (1)
- Predicates its devices cite: 15 (0 its own); citations of its devices by later devices: 21 (0 its own)
- Recalls linked to its devices: 39 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Codman & Shurtleff, Inc.: 5 (https://510kreport.com/company/codman-shurtleff)
- Pudenz-Schulte Medical Research Corp.: 4 (https://510kreport.com/company/pudenz-schulte-medical-research)
- Johnson & Johnson Professionals, Inc.: 3 (https://510kreport.com/company/johnson-johnson-professionals)
- Neuro Navigational Corp.: 1 (https://510kreport.com/company/neuro-navigational)
- Sophysa SA: 1 (https://510kreport.com/company/sophysa)
- Clinical Neuro Systems, LLC: 1 (https://510kreport.com/company/clinical-neuro-systems)

## Firms that cite its devices most
- Medtronic Neurosurgery: 8 (https://510kreport.com/company/medtronic-neurosurgery)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Aqueduct Critical Care, Inc.: 2 (https://510kreport.com/company/aqueduct-critical-care)
- Clarus Medical, LLC: 1 (https://510kreport.com/company/clarus-medical)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Irras, Inc.: 1 (https://510kreport.com/company/irras)
- Neos Surgery S.L: 1 (https://510kreport.com/company/neos-surgery-s-l)

## Its most-cited devices
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 (2002), cited by 6
- K984053: Becker External Drainage and Monitoring System (1999), cited by 5
- K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900 (2001), cited by 2
- K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015 (1999), cited by 2
- K002572: Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (2000), cited by 2
- K010487: Bipolar Pencil, Model 3901-002, 3900-002 (2001), cited by 1

## Recent decisions
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 (Feb 11, 2002)
- K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900 (May 7, 2001)
- K010487: Bipolar Pencil, Model 3901-002, 3900-002 (May 3, 2001)
- K010341: Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, (Apr 20, 2001)
- K003914: Medtronic PS Medical Neuropen Endoscope and Optical Accessories (Feb 22, 2001)
- K002572: Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (Nov 16, 2000)
- K991502: Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022 (Sep 12, 2000)
- K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015 (Apr 28, 1999)

Source page: https://510kreport.com/company/medtronic-ps-medical