Product code OLL

Device name: Septal Stapler/Absorbable Staples
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4750
Review panel: EN
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K082750	ENTACT SEPTAL STAPLER, MODEL 610-00100	Entrigue Surgical, Inc.	2009-01-06

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00817470006452	ENT Sinus	Smith & Nephew, Inc.	2015-08-30
20817470006456	ENT Sinus	Smith & Nephew, Inc.	2015-08-30
00817470006469	ENT Sinus	Smith & Nephew, Inc.	2015-08-30

Related 510(k) Records#