KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ— 510(k) K943176
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K943176 for KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ, Substantially Equivalent on 1994-12-21. Applicant: KARL STORZ Endoscopy-America, Inc..
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code FAJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
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.