VACCON— 510(k) K896733

Name: FDA 510(k) clearance K896733
Creator: U.S. Food and Drug Administration
Published: 1990-02-01

Substantially Equivalent

Unoplast A/S

FDA 510(k) clearance K896733 for VACCON, Substantially Equivalent on 1990-02-01. Applicant: Unoplast A/S. Device class: 1.

Clearance details

Applicant: Unoplast A/S
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1989-11-30
Decision date: 1990-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGX

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K001240 — SERAGARD INJECTION PATCH2000-06-21
K983368 — CARE BAND ANTIBACTERIAL BANDAGES1999-02-17
K972914 — SYVEK PATCH1997-12-22
K943314 — ADHESIVE BANDAGES WITH OTC DRUG1996-01-17
K952606 — TARGETT PATCH1995-12-21

More clearances from Unoplast A/S

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K896734 — FEEDING TUBE1990-12-21
K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER1990-11-05
K896732 — UNOMETER 5001990-11-02
K896730 — SUCTION CATHETER STRAIGHT/COUDE1990-03-30
K896731 — OXYGEN CATHETERS1990-03-30

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.