K172120 is an FDA 510(k) clearance for the Veress Needle. This device is classified as a Pneumoperitoneum Needle (Class II - Special Controls, product code FHO).
Submitted by Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd (Huizhou, CN). The FDA issued a Cleared decision on September 14, 2017, 63 days after receiving the submission on July 13, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. For Establishment Of A Pneumoperitoneum In Abdomen..
| 510(k) Number | K172120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2017 |
| Decision Date | September 14, 2017 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FHO - Pneumoperitoneum Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | For Establishment Of A Pneumoperitoneum In Abdomen. |