STERILE DISPOSABLE INSTRUMENT TRAYS— 510(k) K810004

Substantially Equivalent

Ascep, Inc.

FDA 510(k) clearance K810004 for STERILE DISPOSABLE INSTRUMENT TRAYS, Substantially Equivalent on 1981-01-26. Applicant: Ascep, Inc..

Clearance details

Applicant: Ascep, Inc.
Product code: 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

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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.