EXPANDOVER ELASTIC BANDAGE— 510(k) K880207

Name: FDA 510(k) clearance K880207
Creator: U.S. Food and Drug Administration
Published: 1988-04-21

Substantially Equivalent for Some Indications

Expandover C/O Hale and Dorr

FDA 510(k) clearance K880207 for EXPANDOVER ELASTIC BANDAGE, Substantially Equivalent for Some Indications on 1988-04-21. Applicant: Expandover C/O Hale and Dorr. Device class: 1.

Clearance details

Applicant: Expandover C/O Hale and Dorr
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1988-01-15
Decision date: 1988-04-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Boston, MA, US

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

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.