# Medtronic Neurosurgery

- Location (FDA's records): Goleta, CA
- FDA decisions: 28 (2001–2025): 27 510(k) clearances and 1 De Novo grant
- Product codes: JXG (18), GXQ (4), PCB (2), GXN (1), FZP (1), HWC (1), HBO (1)
- 510(k) review time since 2016: median 136 days, against 123 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 64 (25 its own); citations of its devices by later devices: 36 (25 its own)
- Recalls linked to its devices: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pudenz-Schulte Medical Research Corp.: 18 (https://510kreport.com/company/pudenz-schulte-medical-research)
- Medtronic PS Medical: 8 (https://510kreport.com/company/medtronic-ps-medical)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- P-S Medical: 1 (https://510kreport.com/company/p-s-medical)
- Coalescent Surgical: 1 (https://510kreport.com/company/coalescent-surgical)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Davis & Geck, Inc.: 1 (https://510kreport.com/company/davis-geck)
- Sofamor Danek USA,Inc.: 1 (https://510kreport.com/company/sofamor-danek-usa)

## Firms that cite its devices most
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)
- Collagen Matrix, Inc.: 2 (https://510kreport.com/company/collagen-matrix)
- Medos International SARL: 2 (https://510kreport.com/company/medos-international)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Helios Biomedical, Inc.: 1 (https://510kreport.com/company/helios-biomedical)

## Its most-cited devices
- K042465: PS Medical Strata II Valve (2004), cited by 6
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide (2004), cited by 6
- K040943: Medtronic PS Medical Strata Valve (2004), cited by 5
- K041000: Durepair Dura Regeneration Matrix (2004), cited by 4
- K052211: Durepair Dura Regeneration Matrix (2005), cited by 3
- K161370: Durepair Dura Regeneration Matrix (2016), cited by 2

## Recent decisions
- K243676: Duet External Drainage and Monitoring System (EDMS) (Mar 10, 2025)
- K242034: Duet External Drainage and Monitoring System (EDMS) (Oct 24, 2024)
- K212641: StrataMR II Valves and Shunts (Sep 16, 2021)
- K181622: StrataMR guider tool (Oct 1, 2018)
- K161370: Durepair Dura Regeneration Matrix (Nov 2, 2016)
- K152700: StrataMR Valves and Shunts (Apr 7, 2016)
- DEN120017: Medtronic DUET External Drainage and Monitoring System (Aug 22, 2014)
- K123524: Medtronic Strata NSC Lumboperitoneal Valve and Shunt System (Feb 13, 2013)

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