510(k) · Decided
DecidedGelbfish Endo-Vac System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gary A. Gelbfish · MCW Catheter, Peripheral, Atherectomy
Cleared on Oct 8, 1997 after a 260-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 8, 1997
- Review
- 260 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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 MCW? 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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 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 |
|---|---|---|---|
| * | — | Endovascular suction catheter marketed by the A. S. Aloe Company Named without a submission number | |
| * | — | Endovascular suction catheter marketed by the Klista Company 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.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 5 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Gelbfish Endo-Vac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anti-clogging/self-cleaning mechanism to maintain its uninterrupted function. The device is not (by itself) intended to restore function to clotted AV grafts. It is only used in conjunction with standard percutaneous thrombectomy procedures to facilitate the…
Read the full statement (160 words)
The Gelbfish Endo-Vac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anti-clogging/self-cleaning mechanism to maintain its uninterrupted function.
The device is not (by itself) intended to restore function to clotted AV grafts. It is only used in conjunction with standard percutaneous thrombectomy procedures to facilitate the aspiration of clot from the graft. The arterial and venous anastomotic plug/clot and pathology must still be addressed by standard Fogarty and/or balloon catheter procedures. Expertise in traditional pharmoco-mechanical techniques is necessary, and may be used in conjunction with the Endo-Vac System.
The enclosed device is indicated for use to remove thrombus in clotted synthetic ePTFE grafts only. Its short length makes it suitable for aspiration of clot from the “body” of the graft. It is NOT intended to cross arterial or venous anastomoses or to be used on clot contained in native artery or vein.
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/K970233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970233: Gelbfish Endo-Vac System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970233
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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