K023259

Substantially Equivalent

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200

Applicant: Helix Medical, Inc.
Product code: FDF
Advisory panel: Gastroenterology, Urology
Date received: 2002-09-30
Decision date: 2002-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.