NLU · Class II · 21 CFR 876.4300

FDA Product Code NLU: Forceps, Biopsy, Electric, Reprocessed

The "forceps, Biopsy, Electric, Reprocessed" Are Intended To Be Used Endoscopically And Use Electric Current To (1) Obtain Tissue Samples For Histopathological Examination, (2) Allow For Coagulation So As To Prevent Bleeding, And (3) Destroy The Residuum Of The Lesion Being Biopsied. 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).

4
Total
4
Cleared
78d
Avg days
2001
Since

FDA 510(k) Cleared Forceps, Biopsy, Electric, Reprocessed Devices (Product Code NLU)

4 devices
1–4 of 4
No devices found for this product code.

About Product Code NLU - Regulatory Context