Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument— 510(k) K171825
Substantially EquivalentHunan Handlike Minimally Invasive Surgery Co., Ltd.
FDA 510(k) clearance K171825 for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument, Substantially Equivalent on 2018-02-13. Applicant: Hunan Handlike Minimally Invasive Surgery Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changsha, CN
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More clearances from Hunan Handlike Minimally Invasive Surgery Co., Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.