NLL · Class II · 21 CFR 878.4750

FDA Product Code NLL: Staple, Implantable, Reprocessed

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).

Leading manufacturers include Sterilmed, Inc..

3
Total
3
Cleared
324d
Avg days
2005
Since

FDA 510(k) Cleared Staple, Implantable, Reprocessed Devices (Product Code NLL)

3 devices
1–3 of 3
Cleared Oct 18, 2007
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
K070930
Sterilmed, Inc.
General & Plastic Surgery · 198d
Cleared Sep 12, 2007
REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
K070859
Sterilmed, Inc.
General & Plastic Surgery · 168d

About Product Code NLL - Regulatory Context