DeviceClearance

Product code OLL— General, Plastic Surgery

ENTACT SEPTAL STAPLER, MODEL 610-00100

Classification name
Septal Stapler/Absorbable Staples
Device class
Class 2
Regulation
21 CFR 878.4750
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.”

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

Market context for product code OLL

FDA has cleared 1 device under product code OLL, all in 2009, 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 OLL

Recent clearances under product code OLL

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