CLOTH-HYPOALLERGENIC— 510(k) K840947

Name: FDA 510(k) clearance K840947
Creator: U.S. Food and Drug Administration
Published: 1984-08-17

Substantially Equivalent

Gainor Medical

FDA 510(k) clearance K840947 for CLOTH-HYPOALLERGENIC, Substantially Equivalent on 1984-08-17. Applicant: Gainor Medical. Device class: 1.

Clearance details

Applicant: Gainor Medical
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1984-03-05
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional

Download summary PDF View on FDA.gov ↗

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K952606 — TARGETT PATCH1995-12-21

More clearances from Gainor Medical

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K850100 — BLOOD LANCET1987-01-29
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K844305 — GAINOR MEDICAL FLOWMAX NEEDLES1984-11-30
K844306 — GAINOR MEDICAL SYRINGE1984-11-30
K840945 — SKIN CLOSURE1984-10-31

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.