easyPPHTM Hemorrhoidal Stapler for Single Use— 510(k) K183477
Substantially EquivalentEzisurg Medical Co., Ltd.
FDA 510(k) clearance K183477 for easyPPHTM Hemorrhoidal Stapler for Single Use, Substantially Equivalent on 2019-02-11. 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- K210909 — easyEndo Lite Linear Cutting Stapler and Loading Unit 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.