IRRIGATION PUMPS AND TUBING AND SUCTION TUBING— 510(k) K921457

Substantially Equivalent

American Surgical Instruments Corp.

FDA 510(k) clearance K921457 for IRRIGATION PUMPS AND TUBING AND SUCTION TUBING, Substantially Equivalent on 1993-05-13. Applicant: American Surgical Instruments Corp..

Clearance details

Applicant: American Surgical Instruments Corp.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-26
Decision date: 1993-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delray Beach, FL, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.