SKINCOTE— 510(k) K882567

Substantially Equivalent for Some Indications

Dynarex Corp.

FDA 510(k) clearance K882567 for SKINCOTE, Substantially Equivalent for Some Indications on 1988-10-05. Applicant: Dynarex Corp..

Clearance details

Applicant: Dynarex Corp.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1988-06-22
Decision date: 1988-10-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Brewster, NY, 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.