ENDOSTAPLE— 510(k) K911829
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K911829 for ENDOSTAPLE, Substantially Equivalent on 1991-08-28. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code GCI
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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Adverse events under product code GCI
product code GCI- Malfunction
- 635
- Total
- 635
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.