KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME— 510(k) K961244
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K961244 for KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME, Substantially Equivalent on 1996-05-07. Applicant: KARL STORZ Endoscopy-America, Inc..
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.