K010779 is an FDA 510(k) clearance for the MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT. This device is classified as a Pneumoperitoneum Needle (Class II - Special Controls, product code FHO).
Submitted by Gibbons Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on April 10, 2001, 26 days after receiving the submission on March 15, 2001.
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 | K010779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2001 |
| Decision Date | April 10, 2001 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |