510(k) · Cleared
ClearedSpetzler Scalp Retractor Clamps (Various Styles and Sizes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Mar 18, 2009 as substantially equivalent to K895395 (Baxter Healthcare Corp, 1989) after a 42-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 18, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895395 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895395 V. Mueller Rhoton Self-Retaining Brain RetractorBaxter Healthcare Corp · 1989
- This deviceK090272 Spetzler Scalp Retractor Clamps (Various Styles and Sizes)Cardinal Health, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895395 | V. Mueller Rhoton Self-Retaining Brain Retractor | Baxter Healthcare Corp | 1989 | — |
| 0 (this device) | K090272 | Spetzler Scalp Retractor Clamps (Various Styles and Sizes) | Cardinal Health, Inc. | 2009 | — |
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 GZT? 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 GZT device
- #1 K252995 Durashield Device Kitscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K895395 | V. Mueller Rhoton Self-Retaining Brain RetractorSummary page 1…CFR, 882.4800, Product Code GZT) Predicate Device(s) Rhoton-Merz Self-Retaining Brain Retractor System, K895395 Leyla Self-Retaining Brain Retractor System, Preamendment device ===… | 1989 |
| * | — | Leyla Self-Retaining Brain Retractor System Named without a submission number |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K895395.
How does its category compare?
All GZT devicesGZT Retractor, Self-Retaining, For Neurosurgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GZT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GZT
280in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZT
1in 2012
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GZT
1in 2025
MAUDE reports naming product code GZT, 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 | 2 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 1 (1) | 6 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 3 | 280 | 0 | 9 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are accessories that are intended to be used to assist in the retraction of the scalp during supratentorial and infratentorial skull operations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090272: Spetzler Scalp Retractor Clamps (Various Styles and Sizes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090272
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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