TRANSPARENT ADHESIVE DRESSING— 510(k) K924794

Name: FDA 510(k) clearance K924794
Creator: U.S. Food and Drug Administration
Published: 1993-07-08

Substantially Equivalent

Medical Concepts Development, Inc.

FDA 510(k) clearance K924794 for TRANSPARENT ADHESIVE DRESSING, Substantially Equivalent on 1993-07-08. Applicant: Medical Concepts Development, Inc.. Device class: 1.

Clearance details

Applicant: Medical Concepts Development, Inc.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1992-09-23
Decision date: 1993-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodbury, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGX

view all

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 Medical Concepts Development, Inc.

view all

K020581 — COLOSHIELD COLONOSCOPY DRAPE MODEL E20002002-09-18
K000442 — ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX2001-04-24
K870044 — MCD SPECIALTY BRAND NEEDLE COUNTERS1987-01-21
K861530 — SURGICAL PACKS, KITS AND TRAYS1986-05-30
K861531 — DISPOSABLE SURGICAL DRAPES AND ACCESSORIES1986-05-23

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.