HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR— 510(k) K955120
Substantially EquivalentEthicon Endo-Surgery, Inc.
FDA 510(k) clearance K955120 for HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR, Substantially Equivalent on 1996-01-26. Applicant: Ethicon Endo-Surgery, Inc..
Clearance details
- Applicant
- Ethicon Endo-Surgery, Inc.
- Product code
- Code GCM
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Adverse events under product code GCM
product code GCM- Malfunction
- 1,233
- Total
- 1,233
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.