ENTERON LIVER BIOPSY TRAY— 510(k) K874062

Name: FDA 510(k) clearance K874062
Creator: U.S. Food and Drug Administration
Published: 1987-12-31

Substantially Equivalent

Endovations

FDA 510(k) clearance K874062 for ENTERON LIVER BIOPSY TRAY, Substantially Equivalent on 1987-12-31. Applicant: Endovations. Device class: 2.

Clearance details

Applicant: Endovations
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1987-10-05
Decision date: 1987-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

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More clearances from Endovations

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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 KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.