Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
FDA 510(k) clearance K190029 · decided 2019-09-26
Clearance details
- K-number
- K190029
- Device name
- Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
- Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2019-01-07
- Decision date
- 2019-09-26
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Changzhou, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Changzhou Xin Neng Yuan Medical Stapler Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.