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

Mesh, Surgical, Deployment Balloon

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

OQL is the FDA product code for Mesh, Surgical, Deployment Balloon, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OQL
Device name
Mesh, Surgical, Deployment Balloon
FDA definition
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OQL

By decision year
1 clearance under product code OQL with a decision year between 2010 and 2010, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OQL by decision year
YearClearances
20101

Applicants with the most clearances

Product code OQL
Applicants holding the most 510(k) clearances under product code OQL
ApplicantClearances
Surgical Structures, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code