510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NLXClass II

Needle, Pneumoperitoneum, Spring Loaded, Reprocessed

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NLX is the FDA product code for Needle, Pneumoperitoneum, Spring Loaded, Reprocessed, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NLX
Device name
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
FDA 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).
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLX.