DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE— 510(k) K941206

Name: FDA 510(k) clearance K941206
Creator: U.S. Food and Drug Administration
Published: 1995-07-25

Substantially Equivalent

New Eder Corp.

FDA 510(k) clearance K941206 for DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE, Substantially Equivalent on 1995-07-25. Applicant: New Eder Corp.. Device class: 2.

Clearance details

Applicant: New Eder Corp.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-14
Decision date: 1995-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Groove Village, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HET

view all

K250939 — SIRIUS Endoscope System (PR-SI-1230)2025-08-29
K243821 — i-Cut2025-04-25
K221642 — SIRIUS Endoscope System2022-12-12
K210116 — Video Endoscopy System, 3D Video Endoscopy System2021-10-13
K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-52021-09-17

More clearances from New Eder Corp.

view all

K941435 — BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD1995-04-11
K941207 — MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES1995-01-24
K941208 — DIAGNOSTIC SLEEVE, REDUCER SLEEVE1994-06-17

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.