MODIFIED SPACEMAKER SYSTEM— 510(k) K042412

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K042412 for MODIFIED SPACEMAKER SYSTEM, Substantially Equivalent on 2004-09-24. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2004-09-07
Decision date: 2004-09-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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.