510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OLLClass II

Septal Stapler/Absorbable Staples

21 CFR 878.4750 / General, Plastic Surgery
FDA source (opens on fda.gov)

OLL is the FDA product code for Septal Stapler/Absorbable Staples, a class II device type, regulated under 21 CFR 878.4750. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OLL
Device name
Septal Stapler/Absorbable Staples
FDA 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.
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OLL

By decision year
1 clearance under product code OLL with a decision year between 2009 and 2009, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OLL by decision year
YearClearances
20091

Applicants with the most clearances

Product code OLL
Applicants holding the most 510(k) clearances under product code OLL
ApplicantClearances
Entrigue Surgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code