510(k) Report

510(k) · Cleared

Cleared

Guide Wire

K874164510(k) TraditionalCleared Dec 7, 198755-day reviewClass I21 CFR 876.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endovations · EZB Stylet For Catheter, Gastro-Urology

Cleared on Dec 7, 1987 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 7, 1987
Review
55 days
Class
Class I
Product code
EZB
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K874164Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 EZB devices

EZB 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

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EZB

150in 2025

2007: 332008: 1432009: 4102010: 1392011: 1282012: 1092013: 1602014: 2152015: 532016: 742017: 582018: 462019: 652020: 652021: 692022: 1032023: 1782024: 1332025: 150
2007high 410 (2009) · low 33 (2007)2025

MAUDE reports naming product code EZB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—133
20080—0143
20090—0410
20100—0139
20110—0128
20120—0109
20130—0160
20140—0215
20150—053
20160—074
20170—058
20180—046
20190—065
20200—065
20210—069
20220—0103
20230—0178
20240—0133
20250—0150
20260—0—

More from Endovations

37 FDA decisions under this applicant name. See the company

  • K955413Endovations Triple Lumen Balloon Dilatation CatheterEndovations · 1996
  • K942110Inject-SnareEndovations · 1994
  • K934315Endovations (R) .035 Pre-Cut PapillatomeEndovations · 1994
  • K9138412 Lumen Endos Retro Cholangiopancrea Injec CathEndovations · 1991
  • K9138705MM MicroscissorsEndovations · 1991

Recent decisions in EZB

The EZB category page

  • K971498Applied Medical Laparoscopic GuidewireApplied Medical Resources · 1997
  • K970994Core and Coil Assembly GuidewireLake Region Mfg., Inc. · 1997

https://510kreport.com/device/K874164 · printed Nov 5, 2026

Cite this page

510(k) Report. “K874164: Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K874164

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026