MORWEL ASPIRATOR— 510(k) K841160

Name: FDA 510(k) clearance K841160
Creator: U.S. Food and Drug Administration
Published: 1984-05-31

Substantially Equivalent

Morwel Corp.

FDA 510(k) clearance K841160 for MORWEL ASPIRATOR, Substantially Equivalent on 1984-05-31. Applicant: Morwel Corp.. Device class: 2.

Clearance details

Applicant: Morwel Corp.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1984-03-19
Decision date: 1984-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K233428 — Easycess Aspiration Pump2023-11-03

More clearances from Morwel Corp.

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K962525 — ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM1996-09-19
K841159 — SUCTION TIPS1984-03-19
K831520 — MORWEL CANNULA1983-06-20

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.