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

Snare, Flexible, Reprocessed

21 CFR 876.4300 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NLT is the FDA product code for Snare, Flexible, Reprocessed, a class II device type, regulated under 21 CFR 876.4300. FDA's definition for this code reads: "Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current. This device is indicated 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
NLT
Device name
Snare, Flexible, Reprocessed
FDA definition
Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current. This device is indicated 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 876.4300
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 NLT.