SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK— 510(k) K973046

Substantially Equivalent

General Surgical Innovations

FDA 510(k) clearance K973046 for SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK, Substantially Equivalent on 1998-01-16. Applicant: General Surgical Innovations.

Clearance details

Applicant: General Surgical Innovations
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1997-08-15
Decision date: 1998-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, 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.