Device |
needle, pneumoperitoneum, spring loaded, reprocessed |
Definition |
The "needle, penum...." is intended to insufflate the peritoneal cavity with gas during endoscopic procedures. This device is indiated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). |
Product Code | NLX |
Regulation Number |
876.1500
|
Device Class |
2
|
|
|