510(k) K172120
K172120 is an FDA 510(k) premarket notification submitted by Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd for the device "Veress Needle". The FDA issued a decision of Substantially Equivalent on September 14, 2017. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2017
- Date Received
- July 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pneumoperitoneum Needle
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
For establishment of a pneumoperitoneum in abdomen.