LASER LAPARAXOPE— 510(k) K831241

Name: FDA 510(k) clearance K831241
Creator: U.S. Food and Drug Administration
Published: 1983-06-10

Substantially Equivalent

Eder Instrument Co, Inc.

FDA 510(k) clearance K831241 for LASER LAPARAXOPE, Substantially Equivalent on 1983-06-10. Applicant: Eder Instrument Co, Inc.. Device class: 2.

Clearance details

Applicant: Eder Instrument Co, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1983-04-15
Decision date: 1983-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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 Eder Instrument Co, Inc.

view all

K843498 — BIPOLAR SUCTION ELECTRODE1984-12-14
K843497 — SURGICAL KNIVES & PROBES1984-10-31
K843499 — ARTHROSCOPY LEG HOLDER1984-10-31
K831255 — LARYNGOSCOPE ATTACHMENT PH20001983-09-12
K831240 — LASER BRONCHOSCOPE1983-07-26

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.