DeviceClearance

Product code NVH— General, Plastic Surgery

MEDICINELODGE ZIPKNOT

Classification name
Suture, Knot, Mechanical
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“In approximation and/or ligation of soft tissue”

— U.S. Food and Drug Administration, device classification record for product code NVH under 21 CFR 878.4300, via openFDA

Market context for product code NVH

FDA has cleared 1 device under product code NVH, all in 2005, filed by 1 applicant company. 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.

Top applicants under product code NVH

Recent clearances under product code NVH

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