AQUADERM— 510(k) K885205

Name: FDA 510(k) clearance K885205
Creator: U.S. Food and Drug Administration
Published: 1989-03-29

Substantially Equivalent for Some Indications

Laivan Corp.

FDA 510(k) clearance K885205 for AQUADERM, Substantially Equivalent for Some Indications on 1989-03-29. Applicant: Laivan Corp.. Device class: 1.

Clearance details

Applicant: Laivan Corp.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1988-12-19
Decision date: 1989-03-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Rockaway, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.