K121370 is an FDA 510(k) clearance for the VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE, a Pneumoperitoneum Needle (Class II — Special Controls, product code FHO), submitted by Vectec (Fairfax, US). The FDA issued a Cleared decision on August 2, 2013, 452 days after receiving the submission on May 7, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K121370 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 2012 |
| Decision Date | August 02, 2013 |
| Days to Decision | 452 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. |