easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use— 510(k) K210909
Substantially EquivalentEzisurg Medical Co., Ltd.
FDA 510(k) clearance K210909 for easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use, Substantially Equivalent on 2021-06-24. Applicant: Ezisurg Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ezisurg Medical Co., Ltd.
- 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
- Shanghai, CN
Recent devices under product code GDW
view allMore clearances from Ezisurg Medical Co., Ltd.
view all- K183477 — easyPPHTM Hemorrhoidal Stapler for Single Use
- K181657 — easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
- K172960 — easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
- K143129 — easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler; Loading Unit)
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.