510(k) K895354— INTRASITE CAVITY WOUND DRESSING

Substantially Equivalent for Some Indications

Smith & Nephew United, Inc.

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code KOZ
Advisory panel: General, Plastic Surgery
Date received: 1989-09-01
Decision date: 1989-11-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Largo, FL, US

Adverse events under product code KOZ

product code KOZ

Other: 1
Total: 1

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.