K950495

Substantially Equivalent

SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000

Applicant: Surgical Dynamics, Inc.
Product code: BTA
Advisory panel: General, Plastic Surgery
Date received: 1995-02-06
Decision date: 1995-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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.