MEDICAL ADHESIVE TAPE— 510(k) K860804

Name: FDA 510(k) clearance K860804
Creator: U.S. Food and Drug Administration
Published: 1986-03-24

Substantially Equivalent

W.R. Grace & Co.-Conn.

FDA 510(k) clearance K860804 for MEDICAL ADHESIVE TAPE, Substantially Equivalent on 1986-03-24. Applicant: W.R. Grace & Co.-Conn.. Device class: 1.

Clearance details

Applicant: W.R. Grace & Co.-Conn.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1986-03-04
Decision date: 1986-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, 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.