Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar— 510(k) K190029
Substantially EquivalentChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd
FDA 510(k) clearance K190029 for Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar, Substantially Equivalent on 2019-09-26. Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
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More clearances from Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.