510(k) · Cleared
ClearedApplied Medical Laparoscopic Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · EZB Stylet For Catheter, Gastro-Urology
Cleared on May 5, 1997 as substantially equivalent to K944135 (Applied Medical Resources, 1994) and 1 other predicate after a 10-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- May 5, 1997
- Review
- 10 days
- Class
- Class I
- Product code
- EZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880100 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880100 Cook Urological Wire Guide W/Hydromer CoatingCook Urological, Inc. · 1988
- This deviceK971498 Applied Medical Laparoscopic GuidewireApplied Medical Resources · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880100 | Cook Urological Wire Guide W/Hydromer Coating | Cook Urological, Inc. | 1988 | — |
| 0 (this device) | K971498 | Applied Medical Laparoscopic Guidewire | Applied Medical Resources | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 EZB? 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? (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 |
|---|---|---|---|
| * | K944135 | Urological GuidwireSummary page 1…d Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices… | 1994 |
| * | K880100 | Cook Urological Wire Guide W/Hydromer CoatingSummary page 1…in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowin… | 1988 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All EZB devicesEZB Stylet For Catheter, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZB
FDA has decided no EZB device since 2007.
Median 510(k) review, days · EZB
Too few EZB 510(k)s in any year since 2007 to give a median.
Recalls per year · EZB
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZB
150in 2025
MAUDE reports naming product code EZB, 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 | — | 1 | 33 |
| 2008 | 0 | — | 0 | 143 |
| 2009 | 0 | — | 0 | 410 |
| 2010 | 0 | — | 0 | 139 |
| 2011 | 0 | — | 0 | 128 |
| 2012 | 0 | — | 0 | 109 |
| 2013 | 0 | — | 0 | 160 |
| 2014 | 0 | — | 0 | 215 |
| 2015 | 0 | — | 0 | 53 |
| 2016 | 0 | — | 0 | 74 |
| 2017 | 0 | — | 0 | 58 |
| 2018 | 0 | — | 0 | 46 |
| 2019 | 0 | — | 0 | 65 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 69 |
| 2022 | 0 | — | 0 | 103 |
| 2023 | 0 | — | 0 | 178 |
| 2024 | 0 | — | 0 | 133 |
| 2025 | 0 | — | 0 | 150 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.
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/K971498 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971498: Applied Medical Laparoscopic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971498
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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