KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP— 510(k) K010569

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K010569 for KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP, Substantially Equivalent on 2001-04-09. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-26
Decision date: 2001-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, 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.