DeviceClearance

Product code NLL— General, Plastic Surgery

REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS

Classification name
Staple, Implantable, Reprocessed
Device class
Class 2
Regulation
21 CFR 878.4750
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

FDA classification definition

“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).”

— U.S. Food and Drug Administration, device classification record for product code NLL under 21 CFR 878.4750, via openFDA

Market context for product code NLL

FDA has cleared 3 devices under product code NLL between 2005 and 2007, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NLL

Recent clearances under product code NLL

Data sourced from openFDA. This site is unofficial and independent of the FDA.