510(k) · Cleared
ClearedGeister retractor for neuro - and spine surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geister Medizin Technik GmbH · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Aug 29, 2018 as substantially equivalent to K003740 (Aesculap, Inc., 2001) and 3 other predicates after a 174-day review. Its family tree reaches back 2 generations to 1978. 1 later device descends from it.
- Decided
- Aug 29, 2018
- Review
- 174 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K780706 (1978). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK780706 Lumbar Nerve Root ShieldHeyer Schulte Corp. · 1978
- 1 generation backK003740 Miaspas Minitta Anterior Micro Surgical Transthoracic Approach…Aesculap, Inc. · 2001
- This deviceK180610 Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018
- Descendant · cites it directly · 0 of its ownK252995 Durashield Device KitSurGenTec, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K252995Durashield Device KitSurGenTec, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780706 | Lumbar Nerve Root Shield | Heyer Schulte Corp. | 1978 | — |
| −1 | K003740 | Miaspas Minitta Anterior Micro Surgical Transthoracic Approach Instrumentation | Aesculap, Inc. | 2001 | — |
| 0 (this device) | K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018 | — |
| +1 | K252995 | Durashield Device Kit | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | K003740 | Miaspas Minitta Anterior Micro Surgical Transthoracic Approach InstrumentationSummary page 5…dicate Device 510(k) Number 510(k) Holder miaspas® miniTTA K003740 Aesculap Predicate Devices 510(k) Number 5… | 2001 |
| * | K964402 | Versatrac (TM) Lumbar Retractor SystemSummary page 5…510(k) Number 510(k) Holder Geister® retractor for neuro – and Versatrac™ lumbar retractor system K964402 V.Müller spine suregery Grossman self-retaining low profile brain retractor K0… | 1997 |
| * | K060097 | Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00Summary page 5…ractor system K964402 V.Müller spine suregery Grossman self-retaining low profile brain retractor K060097 KLS Martin Codman lhalo split ring retractor system K913233… | 2006 |
| * | K913233 | Codman Lhalo Split Ring Retractor SystemSummary page 5…self-retaining low profile brain retractor K060097 KLS Martin Codman lhalo split ring retractor system K913233 Codman 4. Description of the Device 4.1. Self-retaining retractor for neurosurgery Dimensions retractor 65mm… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252995 | Durashield Device Kit | 2026 | 0 |
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 40 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K252995 (SurGenTec, LLC, 2026) has gone furthest, with 0 descendants of its own.
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. 2018, 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 device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a selflocking type surgical retraction system with inflatable tissue protectors.
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/K180610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180610: Geister retractor for neuro - and spine surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180610
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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