SIMS SILO NEEDLE DE-ACCESS ENCLOSURE— 510(k) K935767

Substantially Equivalent

Sims Deltec, Inc.

FDA 510(k) clearance K935767 for SIMS SILO NEEDLE DE-ACCESS ENCLOSURE, Substantially Equivalent on 1995-11-15. Applicant: Sims Deltec, Inc..

Clearance details

Applicant: Sims Deltec, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1993-12-02
Decision date: 1995-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.