510(k) · Cleared
ClearedClarus Peel-Away Introducer Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical, LLC · GWG Endoscope, Neurological
Cleared on Mar 18, 2021 as substantially equivalent to K990333 (Medtronic PS Medical, 1999) after a 345-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Mar 18, 2021
- Review
- 345 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883607 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK883607 Peel-Away Introducer for Ventricular CatheterCodman & Shurtleff, Inc. · 1988
- 1 generation backK990333 Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012…Medtronic PS Medical · 1999 · Recalled
- This deviceK200925 Clarus Peel-Away Introducer SheathClarus Medical, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883607 | Peel-Away Introducer for Ventricular Catheter | Codman & Shurtleff, Inc. | 1988 | — |
| −1 | K990333 | Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014… | Medtronic PS Medical | 1999 | 2 |
| 0 (this device) | K200925 | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K990333 | Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015Summary page 4…: 882.1480 Class: II C. Predicate Device: 510(k) Number Description K990333 Medtronic Peelaway Introducer Sheath D. Reference Devices: 510(k) Number Description… | 1999 |
| † | K883607 | Peel-Away Introducer for Ventricular Catheter | 1988 |
| † | K120617 | Ptfe Super Sheath Introducer | 2012 |
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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 21.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K990333.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 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?
The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.
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/K200925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200925: Clarus Peel-Away Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026