FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Miscellaneous
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
3
Product Code
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
LOG
Catheter, Balloon For Retinal Reattachment
3
Product Code
LOH
System, Identification, Contact Lens
3
Product Code
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
3
Product Code
LQB
Medical Computers And Software For Ophthalmic Use
3
Product Code
LQE
Implant, Corneal, Refractive
3
Product Code
LXQ
Cup, Eye
U
Product Code
LYX
Media, Corneal Storage
U
Product Code
LZQ
Tissue Adhesive For Ophthalmic Use
3
Product Code
LZR
Ultrasound, Cyclodestructive
3
Product Code
LZS
Excimer Laser System
3
Product Code
LZU
Plug, Punctum
U
Product Code
MRJ
Ring, Endocapsular
3
Product Code
MSI
Solution, Cleaning / Lubricating, Artificial Eye
3
Product Code
MTA
Lens, Intraocular, Phakic
3
Product Code
MUR
Graft, Sclera, Reinforcement
3
Product Code
MWD
Electrosurgical, Radio Frequency, Refractive Correction
3
Product Code
NBF
Prosthesis, Retinal
F
Product Code
NCJ
Telescope, Implantable, Miniature
3
Product Code
ODK
Refractive Corneal Implant
F
Product Code
OKS
Lacrimal Stents And Intubation Sets
U
Product Code
K
20
1892
Ritleng®+ and Ritleng®+ PVP
U
Cleared 510(K)
K
20
1606
LacriJet®
U
Cleared 510(K)
K
17
0247
Lacriflow CL
U
Cleared 510(K)
K
16
1373
Nunchaku
U
Cleared 510(K)
K
16
0710
Oasis Lacrimal Intubation Set
U
Cleared 510(K)
K
14
2914
DacryoCATH
U
Cleared 510(K)
K
14
0290
STOPLOSS JONES TUBE
U
Cleared 510(K)
K
13
0375
SELF-RETAINING BICANALICULUS INTUBATON SET II
U
Cleared 510(K)
K
12
3831
OPHTACATH KIT
U
Cleared 510(K)
K
12
0886
LACRIFAST
U
Cleared 510(K)
K
11
3316
DCS LACRIMAL STENT
U
Cleared 510(K)
K
11
3867
LACRICATH LACRIMAL DUCT CATHETER
U
Cleared 510(K)
K
11
3508
DACRYOCATH
U
Cleared 510(K)
K
12
1142
CRAWFORD BIOCANALICULUS INTUBATION
U
Cleared 510(K)
K
11
3536
MASTERKA 40 MASTERKA 35 MASTERKA 30
U
Cleared 510(K)
K
11
3118
STENTUBE LACRIMAL INTUBATION SET
U
Cleared 510(K)
K
06
1404
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
U
Cleared 510(K)
K
04
1869
SELF RETAINING BICANALICULUS INTUBATION SET
U
Cleared 510(K)
K
02
3758
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
U
Cleared 510(K)
K
03
0353
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
U
Cleared 510(K)
K
01
2108
MEDPOR COATED TEAR DRAIN
U
Cleared 510(K)
K
99
1238
FCI CRAWFORD PROBE INTUBATION SETS
U
Cleared 510(K)
K
99
0672
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
U
Cleared 510(K)
K
97
3633
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
U
Cleared 510(K)
K
97
3872
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
U
Cleared 510(K)
K
96
2151
RYDER LACRIMAL INTUBATIONSET
U
Cleared 510(K)
K
95
5671
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
U
Cleared 510(K)
K
93
5233
IOLAB LACRIMAL DUCT CATHETER
U
Cleared 510(K)
K
94
0508
OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
U
Cleared 510(K)
K
91
1109
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
U
Cleared 510(K)
K
88
3233
EV MONOCANALICULAR STENT (TM)
U
Cleared 510(K)
OTL
Femtosecond Laser System For Refractive Correction
3
Product Code
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
N
Product Code
PFZ
Ophthalmic Sealant
3
Product Code
QBT
Artificial Iris
3
Product Code
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
3
Product Code
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
2
Product Code
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
2
Product Code
QQJ
Applicator, Negative Pressure, External, Ocular
2
Product Code
SDE
Light Based Device For Dry Age-Related Macular Degeneration
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
OP
/
OP-misc
/
OKS
/
K113316
View Source
DCS LACRIMAL STENT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113316
510(k) Type
Traditional
Applicant
DCS SURGICAL INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/8/2012
Days to Decision
365 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
LZU
Plug, Punctum
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
K
20
1892
Ritleng®+ and Ritleng®+ PVP
K
20
1606
LacriJet®
K
17
0247
Lacriflow CL
K
16
1373
Nunchaku
K
16
0710
Oasis Lacrimal Intubation Set
K
14
2914
DacryoCATH
K
14
0290
STOPLOSS JONES TUBE
K
13
0375
SELF-RETAINING BICANALICULUS INTUBATON SET II
K
12
3831
OPHTACATH KIT
K
12
0886
LACRIFAST
K
11
3316
DCS LACRIMAL STENT
K
11
3867
LACRICATH LACRIMAL DUCT CATHETER
K
11
3508
DACRYOCATH
K
12
1142
CRAWFORD BIOCANALICULUS INTUBATION
K
11
3536
MASTERKA 40 MASTERKA 35 MASTERKA 30
K
11
3118
STENTUBE LACRIMAL INTUBATION SET
K
06
1404
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
K
04
1869
SELF RETAINING BICANALICULUS INTUBATION SET
K
02
3758
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
K
03
0353
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K
01
2108
MEDPOR COATED TEAR DRAIN
K
99
1238
FCI CRAWFORD PROBE INTUBATION SETS
K
99
0672
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
K
97
3633
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K
97
3872
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K
96
2151
RYDER LACRIMAL INTUBATIONSET
K
95
5671
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
K
93
5233
IOLAB LACRIMAL DUCT CATHETER
K
94
0508
OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
K
91
1109
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
K
88
3233
EV MONOCANALICULAR STENT (TM)
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
OKS
/
K113316
View Source
DCS LACRIMAL STENT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K113316
510(k) Type
Traditional
Applicant
DCS SURGICAL INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/8/2012
Days to Decision
365 days
Submission Type
Summary