AIRLIFT BALLOON RETRACTON SYSTEM— 510(k) K962104

Substantially Equivalent

Origin Medsystems, Inc.

FDA 510(k) clearance K962104 for AIRLIFT BALLOON RETRACTON SYSTEM, Substantially Equivalent on 1996-09-11. Applicant: Origin Medsystems, Inc..

Clearance details

Applicant: Origin Medsystems, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-30
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, 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.