DeviceClearance

Product code NUJ— General, Plastic Surgery

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

Classification name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
37
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 NUJ under 21 CFR 878.4400, via openFDA

Market context for product code NUJ

FDA has cleared 37 devices under product code NUJ between 2001 and 2024, filed by 15 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

last 15 years

Top applicants under product code NUJ

Recent clearances under product code NUJ

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