MSI SURGI-GRADE INCISION & DRAIN TRAY— 510(k) K843563

Substantially Equivalent

Medical Sterilization, Inc.

FDA 510(k) clearance K843563 for MSI SURGI-GRADE INCISION & DRAIN TRAY, Substantially Equivalent on 1984-10-23. Applicant: Medical Sterilization, Inc..

Clearance details

Applicant: Medical Sterilization, Inc.
Product code: Code FSM
Advisory panel: General, Plastic Surgery
Date received: 1984-09-10
Decision date: 1984-10-23
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.