GRAMS ASPIRATOR S-300— 510(k) K840803

Substantially Equivalent

Grams Medical, Inc.

FDA 510(k) clearance K840803 for GRAMS ASPIRATOR S-300, Substantially Equivalent on 1984-05-21. Applicant: Grams Medical, Inc..

Clearance details

Applicant: Grams Medical, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1984-02-24
Decision date: 1984-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.