LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001— 510(k) K023735

Substantially Equivalent

Medsys, S.A.

FDA 510(k) clearance K023735 for LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001, Substantially Equivalent on 2003-08-07. Applicant: Medsys, S.A..

Clearance details

Applicant: Medsys, S.A.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2002-11-07
Decision date: 2003-08-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Puyallup, WA, 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.