SCLEROTHERAPY INJECTION CATHETER— 510(k) K860991

Name: FDA 510(k) clearance K860991
Creator: U.S. Food and Drug Administration
Published: 1986-05-02

Substantially Equivalent

Endovations

FDA 510(k) clearance K860991 for SCLEROTHERAPY INJECTION CATHETER, Substantially Equivalent on 1986-05-02. Applicant: Endovations. Device class: 2.

Clearance details

Applicant: Endovations
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1986-03-17
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

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K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER1996-02-08
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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 KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.