NON-ADHERING DRESSING WITH POVIDONE-IODINE— 510(k) K861384

Substantially Equivalent for Some Indications

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K861384 for NON-ADHERING DRESSING WITH POVIDONE-IODINE, Substantially Equivalent for Some Indications on 1986-07-01. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1986-04-14
Decision date: 1986-07-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.