INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200— 510(k) K023259

Substantially Equivalent

Helix Medical, Inc.

FDA 510(k) clearance K023259 for INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200, Substantially Equivalent on 2002-12-26. Applicant: Helix Medical, Inc..

Clearance details

Applicant: Helix Medical, Inc.
Product code: 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

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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.