510(k) · Cleared
ClearedSuction Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Cleared on Jul 25, 1997 after a 52-day review. The FDA summary names no predicate by number.
- Decided
- Jul 25, 1997
- Review
- 52 days
- Class
- Class II
- Product code
- GCX
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 GCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by 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.
How does its category compare?
All GCX devicesGCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCX
FDA has decided no GCX device since 2007.
Median 510(k) review, days · GCX
Too few GCX 510(k)s in any year since 2007 to give a median.
Recalls per year · GCX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCX
274in 2025
MAUDE reports naming product code GCX, 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 | 24 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 40 |
| 2010 | 0 | — | 0 | 51 |
| 2011 | 0 | — | 0 | 67 |
| 2012 | 0 | — | 0 | 242 |
| 2013 | 0 | — | 1 | 47 |
| 2014 | 0 | — | 0 | 32 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 99 |
| 2017 | 0 | — | 1 | 45 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 0 | — | 0 | 65 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 72 |
| 2023 | 0 | — | 3 | 59 |
| 2024 | 0 | — | 1 | 65 |
| 2025 | 0 | — | 0 | 274 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The suction devices, when attached to an external source of vacuum, are used for aspiration, removal, or sampling of body fluids during surgical procedures.
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/K972074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972074: Suction Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026