HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE— 510(k) K050163
Substantially EquivalentHenke Sass Wolf of America, Inc.
FDA 510(k) clearance K050163 for HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE, Substantially Equivalent on 2005-03-24. Applicant: Henke Sass Wolf of America, Inc..
Clearance details
- Applicant
- Henke Sass Wolf of America, Inc.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flemington, NJ, US
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.