GUIDE WIRE— 510(k) K874164

Name: FDA 510(k) clearance K874164
Creator: U.S. Food and Drug Administration
Published: 1987-12-07

Substantially Equivalent

Endovations

FDA 510(k) clearance K874164 for GUIDE WIRE, Substantially Equivalent on 1987-12-07. Applicant: Endovations. Device class: 1.

Clearance details

Applicant: Endovations
Product code: Code EZB
Device class: Class 1
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1987-10-13
Decision date: 1987-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZB

view all

K971498 — APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE1997-05-05
K970994 — CORE AND COIL ASSEMBLY GUIDEWIRE1997-03-25

More clearances from Endovations

view all

K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER1996-02-08
K942110 — INJECT-SNARE1994-10-13
K934315 — ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME1994-02-28
K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH1991-10-08
K913870 — 5MM MICROSCISSORS1991-09-16

Adverse events under product code EZB

product code EZB

Death: 4
Injury: 141
Malfunction: 588
Total: 733

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.