510(k) · Cleared

Cleared

Paediscope, Model # P010A and PF011A

K014149510(k) TraditionalCleared Mar 18, 200290-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

Aesculap, Inc. · GWG Endoscope, Neurological

Cleared on Mar 18, 2002 as substantially equivalent to K983365 (Aesculap, Inc., 1998) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1995.

Decided: Mar 18, 2002
Review: 90 days
Class: Class II
Product code: GWG
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K954899 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK954899 Rigid Neuroview EndoscopeNeuro Navigational Corp. · 1995
This deviceK014149 Paediscope, Model # P010A and PF011AAesculap, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954899	Rigid Neuroview Endoscope	Neuro Navigational Corp.	1995	—
0 (this device)	K014149	Paediscope, Model # P010A and PF011A	Aesculap, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
2000	2	0

FIG. 1 — Lineage of K014149, 1995–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K983365	Aesculap Minop System Summary page 2 …/=2 SUBSTANTIAL EQUIVALENCE The new Paediscope described in this premarket notification is substantially equivalent to those predicate devices: . Aesculap MINOP System (K983365) . Aesculap Ventriculoscope System (K954394) . Neuro Navigational Neuroview (K954899) . Medtronic PSMedical Channel Neuroscope (K…	Aesculap, Inc.	1998	3
*	K954394	Aesculap Ventriculoscope System Summary page 2 …pe described in this premarket notification is substantially equivalent to those predicate devices: . Aesculap MINOP System (K983365) . Aesculap Ventriculoscope System (K954394) . Neuro Navigational Neuroview (K954899) . Medtronic PSMedical Channel Neuroscope (K002572) . Storz Miniature Neuroendoscope (K0…	Aesculap, Inc.	1996	—
*	K954899	Rigid Neuroview Endoscope Summary page 2 …on is substantially equivalent to those predicate devices: . Aesculap MINOP System (K983365) . Aesculap Ventriculoscope System (K954394) . Neuro Navigational Neuroview (K954899) . Medtronic PSMedical Channel Neuroscope (K002572) . Storz Miniature Neuroendoscope (K002704) § WEALTY 5 O %4,…	Neuro Navigational Corp.	1995	—
*	K002572	Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003… Summary page 2 …devices: . Aesculap MINOP System (K983365) . Aesculap Ventriculoscope System (K954394) . Neuro Navigational Neuroview (K954899) . Medtronic PSMedical Channel Neuroscope (K002572) . Storz Miniature Neuroendoscope (K002704) § WEALTY 5 O %4, & o SERVICEg & Sl 2 C DEPARTMENT OF HEALTH & HUMA…	Medtronic PS Medical	2000	—
*	K002704	Ksea Miniature Neuroendoscope Summary page 2 …. Aesculap Ventriculoscope System (K954394) . Neuro Navigational Neuroview (K954899) . Medtronic PSMedical Channel Neuroscope (K002572) . Storz Miniature Neuroendoscope (K002704) § WEALTY 5 O %4, & o SERVICEg & Sl 2 C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ‘ _ . ‘ F…	KARL STORZ Endoscopy-America, Inc.	2000	—

Also cleared against K983365: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 5 ancestors has a recall of any class.
2 other devices also cite its predicate K983365.

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

2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWG

269in 2023

2007high 269 (2023) · low 106 (2021)2026

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

Recalls per year · GWG

2in 2011

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	3
2008	2	—	0	5
2009	0	—	1	0
2010	0	—	0	1
2011	0	—	2	4
2012	0	—	0	7
2013	1	—	0	3
2014	2	—	0	19
2015	0	—	0	37
2016	2	—	0	25
2017	4	126	0	12
2018	4	128	0	16
2019	3	156	0	10
2020	2	—	0	19
2021	3	106	0	21
2022	0	—	0	12
2023	5	269	0	9
2024	1	—	0	9
2025	2	—	0	33
2026	4	217	0	—

What is it indicated for?

Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014149 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014149: Paediscope, Model # P010A and PF011A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014149

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026