ENDOSCOPE INTRODUCER KIT— 510(k) K955717
Substantially EquivalentMitsubishi Cable America, Inc.
FDA 510(k) clearance K955717 for ENDOSCOPE INTRODUCER KIT, Substantially Equivalent on 1996-04-18. Applicant: Mitsubishi Cable America, Inc..
Clearance details
- Applicant
- Mitsubishi Cable America, Inc.
- Product code
- Code FDE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Villa Park, CA, US
Adverse events under product code FDE
product code FDE- Other
- 1
- Total
- 1
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.