SYVEK PATCH— 510(k) K972914

Substantially Equivalent

Marine Polymer Technologies, Inc.

FDA 510(k) clearance K972914 for SYVEK PATCH, Substantially Equivalent on 1997-12-22. Applicant: Marine Polymer Technologies, Inc..

Clearance details

Applicant: Marine Polymer Technologies, Inc.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1997-08-07
Decision date: 1997-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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.