INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200— 510(k) K023259
Substantially EquivalentHelix 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.. Device class: 2.
Clearance details
- Applicant
- Helix Medical, Inc.
- Product code
- Code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- 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, through . 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.