MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE— 510(k) K972926
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K972926 for MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE, Substantially Equivalent on 1997-10-08. Applicant: KARL STORZ Endoscopy-America, Inc..
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code FBN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Adverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
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.