NLX

Needle, Pneumoperitoneum, Spring Loaded, Reprocessed

Product code

NLX

Device name

Needle, Pneumoperitoneum, Spring Loaded, Reprocessed

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).