510(k) Report

510(k) · Cleared

Cleared

Medtronic PS Medical Neuropen Endoscope and Optical Accessories

K003914510(k) AbbreviatedCleared Feb 22, 200165-day reviewClass II21 CFR 882.1480

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic PS Medical · GWG Endoscope, Neurological

Cleared on Feb 22, 2001 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 22, 2001
Review
65 days
Class
Class II
Product code
GWG
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared200020052010201520202025
  1. This deviceK003914 Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesMedtronic PS Medical · 2001
  2. Descendant · cites it directly · 0 of its ownK170462 KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003914Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesMedtronic PS Medical2001—
+1K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K003914, 2001–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GWG device

  1. #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc.20170

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K170462 (KARL STORZ Endoscopy-America, Inc., 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GWG devices

GWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWG

2in 2025

2008: 22013: 12014: 22016: 22017: 42018: 42019: 32020: 22021: 32023: 52024: 12025: 22026 (partial year): 4
2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWG

269in 2023

2017: 126 days median2018: 128 days median2019: 156 days median2021: 106 days median2023: 269 days median2026 (partial year): 217 days median
2007high 269 (2023) · low 106 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWG

2in 2011

2009: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWG

33in 2025

2007: 32008: 52010: 12011: 42012: 72013: 32014: 192015: 372016: 252017: 122018: 162019: 102020: 192021: 212022: 122023: 92024: 92025: 33
2007high 37 (2015) · low 0 (2009)2025

MAUDE reports naming product code GWG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20082—05
20090—10
20100—01
20110—24
20120—07
20131—03
20142—019
20150—037
20162—025
20174126012
20184128016
20193156010
20202—019
20213106021
20220—012
2023526909
20241—09
20252—033
202642170—

More from Medtronic PS Medical

14 FDA decisions under this applicant name. See the company

  • 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
  • K002572Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005Medtronic PS Medical · 2000

Recent decisions in GWG

The GWG category page

  • K260315cCeLL - In vivoVPIX Medical, Inc. · 2026
  • K260581KARL STORZ Flexible Video Neuro-EndoscopeKarl Storz SE & CO. KG · 2026
  • K253602Precision S 4K SinuscopeStryker Endoscopy · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026
  • K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2025

https://510kreport.com/device/K003914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003914: Medtronic PS Medical Neuropen Endoscope and Optical Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003914

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026