POROUS, BREATHING TAPE W/RELEASE LINER— 510(k) K802752

Name: FDA 510(k) clearance K802752
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

Bioadhesive Systems, Inc.

FDA 510(k) clearance K802752 for POROUS, BREATHING TAPE W/RELEASE LINER, Substantially Equivalent on 1980-12-10. Applicant: Bioadhesive Systems, Inc.. Device class: 1.

Clearance details

Applicant: Bioadhesive Systems, Inc.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1980-11-03
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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

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.