DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005— 510(k) K003790

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K003790 for DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005, Substantially Equivalent on 2000-12-22. Applicant: Davol, Inc..

Clearance details

Applicant: Davol, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2000-12-08
Decision date: 2000-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, 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.