DeviceClearance

Product code PDG— General, Plastic Surgery

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS

Classification name
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.”

— U.S. Food and Drug Administration, device classification record for product code PDG under 21 CFR 878.4400, via openFDA

Market context for product code PDG

FDA has cleared 1 device under product code PDG, all in 2013, 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 PDG

Recent clearances under product code PDG

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