510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OKSUnclassified

Lacrimal Stents And Intubation Sets

Unknown
FDA source (opens on fda.gov)

OKS is the FDA product code for Lacrimal Stents And Intubation Sets. FDA's definition for this code reads: "Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring...". As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OKS
Device name
Lacrimal Stents And Intubation Sets
FDA definition
Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
31
Ingested recalls
0

Clearances, product code OKS

By decision year
31 clearances under product code OKS with a decision year between 1988 and 2021, 2012 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code OKS by decision year
YearClearances
19881
19911
19942
19962
19982
19992
20011
20032
20041
20061
20127
20132
20141
20151
20162
20171
20201
20211

Applicants with the most clearances

Product code OKS
Applicants holding the most 510(k) clearances under product code OKS
ApplicantClearances
Fci Ophthalmics, Inc.4
Fci SAS (France Chirurgie Instrumentation)3
G.W.B. Intl., Ltd.3
Armadillo Biomedical, LLC2
Atrion Medical Products, Inc.2
Grace Medical, Inc.2
Fci (France Chirurgie Instrumentation) SAS2
Quest Medical, Inc2
Anodyne1
Chiron Vision Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order