K810004

Substantially Equivalent

STERILE DISPOSABLE INSTRUMENT TRAYS

Applicant: Ascep, Inc.
Product code: FSM
Advisory panel: General, Plastic Surgery
Date received: 1981-01-06
Decision date: 1981-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.