SURGICAL LASER ACCESSORIES (SLA) CASE— 510(k) K862629

Substantially Equivalent

Simpson/Basye, Inc.

FDA 510(k) clearance K862629 for SURGICAL LASER ACCESSORIES (SLA) CASE, Substantially Equivalent on 1986-07-17. Applicant: Simpson/Basye, Inc..

Clearance details

Applicant: Simpson/Basye, Inc.
Product code: Code FSM
Advisory panel: General, Plastic Surgery
Date received: 1986-07-10
Decision date: 1986-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, 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.