510(k) Report

FDA applicant

Medtronic PS Medical

Goleta, CA14 decisions1996–200239 recalls

FDA records 14 decisions for Medtronic PS Medical (Goleta, CA) from 1996 to 2002: 14 510(k) clearances. Most are in product codes GWG (Endoscope, Neurological) and JXG (Shunt, Central Nervous System And Components). Its devices cite 15 predicates, 0 of them its own earlier devices. 39 recalls are linked to its devices, 5 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Medtronic PS Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic PS Medical since 2007.

Recalls per year

1in 2023

2009: 292014: 5, 5 Class I2023: 1
2007high 29 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic PS Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic PS Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GWGEndoscope, Neurological4decisions
  • JXGShunt, Central Nervous System And Components4decisions
  • GXRCover, Burr Hole1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • HCACatheter, Ventricular1decision
  • LISUnnamed device1decision

Also: LJS (1), GWM (1).

Whose devices does it build on?

Its devices cite 15 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 20026cite it
  • K984053Becker External Drainage and Monitoring SystemMedtronic PS Medical · 19995cite it
  • K010361Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900Medtronic PS Medical · 20012cite it
  • K990333Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015Medtronic PS Medical · 19992cite it
  • K002572Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005Medtronic PS Medical · 20002cite it
  • K010487Bipolar Pencil, Model 3901-002, 3900-002Medtronic PS Medical · 20011cites it

What has FDA decided for it lately?

  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
  • K010361Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900Medtronic PS Medical · 2001
  • K010487Bipolar Pencil, Model 3901-002, 3900-002Medtronic PS Medical · 2001
  • K010341Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161…Medtronic PS Medical · 20012 recalls
  • K003914Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesMedtronic PS Medical · 2001
  • K002572Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005Medtronic PS Medical · 2000
  • K991502Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022Medtronic PS Medical · 2000
  • K990333Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015Medtronic PS Medical · 19992 recalls

All 14 as Medtronic PS Medical →

What has been recalled?

39 recalls linked to its devices; the latest:

  • K984053Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection…Jun 28, 2023Class II
  • K984053Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites…Jun 9, 2014Class I
  • K984053Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites…Jun 9, 2014Class I
  • K984053Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites…Jun 9, 2014Class I
  • K984053Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites…Jun 9, 2014Class I
  • K984053Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites…Jun 9, 2014Class I