GI SUPPLY PARACENTESIS PUMP— 510(k) K970186

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K970186 for GI SUPPLY PARACENTESIS PUMP, Substantially Equivalent on 1997-02-14. Applicant: Gi Supply.

Clearance details

Applicant: Gi Supply
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1997-01-17
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willington, CT, 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.