AQUA-GARD WATERPROOF WOUND PATCH— 510(k) K905022

Name: FDA 510(k) clearance K905022
Creator: U.S. Food and Drug Administration
Published: 1991-02-11

Substantially Equivalent

Bellhouse Medical, Inc.

FDA 510(k) clearance K905022 for AQUA-GARD WATERPROOF WOUND PATCH, Substantially Equivalent on 1991-02-11. Applicant: Bellhouse Medical, Inc.. Device class: 1.

Clearance details

Applicant: Bellhouse Medical, Inc.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1990-11-07
Decision date: 1991-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Elmo, MN, 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.