Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler— 510(k) K150026
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K150026 for Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler, Substantially Equivalent on 2015-05-18. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guaynabo, PR
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Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.