LS1000 SURGICAL ASPIRATOR II— 510(k) K854844

Substantially Equivalent for Some Indications

Engineering, Inc.

FDA 510(k) clearance K854844 for LS1000 SURGICAL ASPIRATOR II, Substantially Equivalent for Some Indications on 1986-02-12. Applicant: Engineering, Inc..

Clearance details

Applicant: Engineering, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1985-12-04
Decision date: 1986-02-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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.