VISULIN TRANSPARENT ADHESIVE DRESSING— 510(k) K894147

Clearance details

Applicant

James River Corp.

Product code

Code KGX

Device class

Class 1

Regulation

21 CFR 880.5240

Advisory panel

General Hospital

Date received

1989-06-14

Decision date

1989-08-09

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Neenah, WI, US

• 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

• K894505 — COTOLIN DRAIN SPONGE AND DRESSING SPONGE1989-09-15
• K892580 — CARETOUCH EXAMINATION GLOVES1989-07-14
• K893939 — ISOLATION MASKS1989-07-14
• K894034 — MODIFIED LABELING OF SURGICAL GLOVES1989-07-14
• K890459 — JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES1989-04-20

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 →