We're working on improving this tool, so please
email us
suggestions.
Sign up
for email updates to learn about new features.
✕
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
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
HLD
Engine, Trephine, Accessories, Gas-Powered
1
Product Code
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
2
Product Code
FCT
Headlight, Fiberoptic Focusing
2
Product Code
FSR
Light, Headband, Surgical
2
Product Code
FTZ
Locator, Magnetic
1
Product Code
HMQ
Marker, Sclera
1
Product Code
HMR
Marker, Ocular
1
Product Code
HMS
Drum, Eye Knife Test
1
Product Code
HMX
Cannula, Ophthalmic
1
Product Code
HMY
Keratome, Battery-Powered
1
Product Code
HMZ
Trabeculotome
1
Product Code
HNA
Spud, Ophthalmic
1
Product Code
HNB
Spoon, Ophthalmic
1
Product Code
HNC
Specula, Ophthalmic
1
Product Code
HND
Spatula, Ophthalmic
1
Product Code
HNE
Snare, Enucleating
1
Product Code
HNF
Scissors, Ophthalmic
1
Product Code
HNG
Rongeur, Lachrymal Sac
1
Product Code
HNH
Ring, Ophthalmic (Flieringa)
1
Product Code
HNI
Retractor, Ophthalmic
1
Product Code
HNJ
Punch, Corneo-Scleral
1
Product Code
HNK
Probe, Trabeculotomy
1
Product Code
HNL
Probe, Lachrymal
1
Product Code
HNM
Needle, Ophthalmic Suturing
1
Product Code
HNN
Knife, Ophthalmic
1
Product Code
HNO
Keratome, Ac-Powered
1
Product Code
HNP
Introducer, Sphere
1
Product Code
HNQ
Hook, Ophthalmic
1
Product Code
HNR
Forceps, Ophthalmic
1
Product Code
HNS
Expressor
1
Product Code
HNT
Erisophake
1
Product Code
HNW
Dilator, Lachrymal
1
Product Code
HNX
Depressor, Orbital
1
Product Code
HNY
Cystotome
1
Product Code
HNZ
Curette, Ophthalmic
1
Product Code
HOA
Compressor, Orbital
1
Product Code
HOB
Clamp, Muscle, Ophthalmic
1
Product Code
HOC
Clip, Iris Retractor
1
Product Code
HOD
Clamp, Eyelid, Ophthalmic
1
Product Code
HOE
Caliper, Ophthalmic
1
Product Code
HOF
Burr, Corneal, Manual
1
Product Code
HOG
Burr, Corneal, Battery-Powered
1
Product Code
HOH
Spectacle, Operating (Loupe), Ophthalmic
1
Product Code
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
1
Product Code
HOZ
Sponge, Ophthalmic
2
Product Code
HPM
Locator, Metal, Electronic
2
Product Code
HPN
Magnet, Permanent
1
Product Code
HPO
Magnet, Ac-Powered
2
Product Code
HPP
Headlamp, Operating, Battery-Operated
1
Product Code
HPQ
Headlamp, Operating, Ac-Powered
2
Product Code
HPS
Unit, Cryophthalmic
2
Product Code
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
1
Product Code
HQA
Unit, Cryotherapy, Ophthalmic
2
Product Code
HQB
Photocoagulator And Accessories
2
Product Code
HQC
Unit, Phacofragmentation
2
Product Code
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
2
Product Code
K
17
0183
Cetus system, Cetus probe
2
Cleared 510(K)
K
15
3168
Bi-Blade Vitrectomy Cutter
2
Cleared 510(K)
K
14
1065
CONSTELLATION VISION SYSTEM
2
Cleared 510(K)
K
12
1675
VERSAVIT
2
Cleared 510(K)
K
12
0170
PROCARE PLUS VITRECTOMY SYSTEM
2
Cleared 510(K)
K
10
2222
ULTIMATE VIT ENHAMCER (UVE)
2
Cleared 510(K)
K
03
3390
COLIBRI DISPOSABLE VITRECTOMY CUTTER
2
Cleared 510(K)
K
03
0948
VMATE MODEL VMM1000
2
Cleared 510(K)
K
02
3939
VELOCITY ADVANTAGE
2
Cleared 510(K)
K
02
0911
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
2
Cleared 510(K)
K
01
0082
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
2
Cleared 510(K)
K
99
2943
VIT ENHANCER
2
Cleared 510(K)
K
99
0292
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
2
Cleared 510(K)
K
98
3797
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
2
Cleared 510(K)
K
98
0400
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
2
Cleared 510(K)
K
98
0399
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
2
Cleared 510(K)
K
98
0488
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
2
Cleared 510(K)
K
97
0670
REUSABLE VITRECTOMY PROBE
2
Cleared 510(K)
K
97
0673
DISPOSABLE VITRECTOMY PROBE
2
Cleared 510(K)
K
96
4743
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
2
Cleared 510(K)
K
96
1738
VIT COMMANDER SYSTEM
2
Cleared 510(K)
K
96
0061
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
2
Cleared 510(K)
K
96
1078
AUTOMATED VITRECTOMY DEVICE
2
Cleared 510(K)
K
95
4816
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
2
Cleared 510(K)
K
95
3576
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
2
Cleared 510(K)
K
95
3575
STORZ MVS-3201 VITRECTOMY PROBE PACK
2
Cleared 510(K)
K
95
0852
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
2
Cleared 510(K)
K
95
0799
PRO-VIT
2
Cleared 510(K)
K
94
6135
INFINITECH ASPIRATING LASER PROBE
2
Cleared 510(K)
K
94
6181
INFINITECH SOFT TIP FLUTE NEEDLE
2
Cleared 510(K)
K
93
4600
MICRODRIVE
2
Cleared 510(K)
K
93
6302
NIDEK MODEL VT-4000, MODIFICATION
2
Cleared 510(K)
K
94
0391
PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
2
Cleared 510(K)
K
94
0746
VIT CUTTER MODEL 94
2
Cleared 510(K)
K
93
2669
SUPRA-VIT(TM)
2
Cleared 510(K)
K
93
0842
THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
2
Cleared 510(K)
K
93
3907
STORZ FIBEROPTIC PICK MANIPULATOR
2
Cleared 510(K)
K
93
2668
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
2
Cleared 510(K)
K
93
4204
INTERTIP INFUSION SET
2
Cleared 510(K)
K
93
3984
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
2
Cleared 510(K)
K
93
3208
BARE-FIBER ENDOILLUMINATOR
2
Cleared 510(K)
K
92
4353
NIDEK MODEL VST-4000
2
Cleared 510(K)
K
92
4222
MID LABS, INC. VIT MATE
2
Cleared 510(K)
K
92
4604
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
2
Cleared 510(K)
K
92
2355
POLLY'S VITREOUS SCISSORS J-225-S
2
Cleared 510(K)
K
92
1758
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
2
Cleared 510(K)
K
92
1460
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
2
Cleared 510(K)
K
92
0718
DISPOSABLE POSTERIOR MICROSCISSORS
2
Cleared 510(K)
K
92
0582
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
2
Cleared 510(K)
K
91
5745
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
2
Cleared 510(K)
K
91
3504
STORZ MICRO CUTTER 25 GAUGE PACK
2
Cleared 510(K)
K
91
3261
DWYER EYE SYSTEMS ASPIRATION UNIT
2
Cleared 510(K)
K
91
2384
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
2
Cleared 510(K)
K
91
4038
POLLY'S CUTTER J-225
2
Cleared 510(K)
K
91
3837
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
2
Cleared 510(K)
K
91
4221
KPE 220 TS, NONSTERILE
2
Cleared 510(K)
K
91
2253
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
2
Cleared 510(K)
K
91
1998
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
2
Cleared 510(K)
K
91
0973
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
2
Cleared 510(K)
K
90
4909
I/A VITROPHAGE MODEL YPR 2001
2
Cleared 510(K)
K
89
5813
GLAUCOMA MECHANICAL TREPHINE
2
Cleared 510(K)
K
89
6943
SITE DISPOSABLE CUTTER AND ACCESSORIES
2
Cleared 510(K)
K
89
4248
CONVERTER SYSTEM
2
Cleared 510(K)
K
89
6754
I/A HANDPIECE
2
Cleared 510(K)
K
89
6305
MULTI-USE I/A HANDPIECE
2
Cleared 510(K)
K
89
4278
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
2
Cleared 510(K)
K
89
0195
JAMES SURGICAL SYSTEM J1000
2
Cleared 510(K)
K
89
1601
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
2
Cleared 510(K)
K
88
4557
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
2
Cleared 510(K)
K
89
0622
SURG-E-TROL SYSTEM I AND SYSTEM II
2
Cleared 510(K)
K
89
0300
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
2
Cleared 510(K)
K
89
0133
OCULAR CONNECTION MACHINE(TM)
2
Cleared 510(K)
K
89
0544
SHAPIRO CUTTER
2
Cleared 510(K)
K
88
4556
DREYER CURVED ENDOILLUMINATOR
2
Cleared 510(K)
K
88
5196
LASER INDIRECT OPHTHALMOSCOPE (LIO)
2
Cleared 510(K)
K
88
4043
GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
2
Cleared 510(K)
K
88
3926
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
2
Cleared 510(K)
K
88
3975
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
2
Cleared 510(K)
K
88
3605
MODIFIED REUSABLE SITE FIBER OPTIC CABLE
2
Cleared 510(K)
K
88
1519
VAC-G (GUILLOTINE VITRECTOR)
2
Cleared 510(K)
K
88
1520
VAC (OSCILLATING VITRECTOR)
2
Cleared 510(K)
K
88
0943
MICROLINE CAT #100
2
Cleared 510(K)
K
88
1927
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
2
Cleared 510(K)
K
88
0929
NIDEK CV-4000
2
Cleared 510(K)
K
88
0968
MODEL 2001 PHACOEMULSIFIER ASPIRATOR
2
Cleared 510(K)
K
87
2312
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
2
Cleared 510(K)
K
87
1871
SERIES TEN THOUSAND OCUTOME
2
Cleared 510(K)
K
87
1375
SITE PERISTALTIC MODULE SYSTEM
2
Cleared 510(K)
K
87
0775
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
2
Cleared 510(K)
K
87
0068
ASPIRATION REVERSAL CONTROL (ARC) MODULE
2
Cleared 510(K)
K
86
4035
VES-10 INTRAOCULAR SCISSORS DRIVE
2
Cleared 510(K)
K
86
2943
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
2
Cleared 510(K)
K
86
2188
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
2
Cleared 510(K)
K
86
2343
VACUUM HANDLE MODEL I/A - 1
2
Cleared 510(K)
K
86
1565
SERIES TEN THOUSAND COMPACT
2
Cleared 510(K)
K
86
1380
SERIES TEN THOUSAND MASTER
2
Cleared 510(K)
K
86
0891
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
2
Cleared 510(K)
K
86
0014
SYSTEMS PLUS
2
Cleared 510(K)
K
85
4868
I/A - VFE SYSTEM II
2
Cleared 510(K)
K
85
4871
MICRO SURGICAL SYSTEM
2
Cleared 510(K)
K
83
4162
VIT PAC
2
Cleared 510(K)
K
83
4160
VITREONIC PLUS
2
Cleared 510(K)
K
85
4508
STORZ DAISY
2
Cleared 510(K)
K
85
3430
STORZ IAS DISPOSABLE PACK
2
Cleared 510(K)
K
85
3961
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
2
Cleared 510(K)
K
85
3457
COBURN I/A SYSTEM
2
Cleared 510(K)
K
85
3382
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
2
Cleared 510(K)
K
85
3308
KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
2
Cleared 510(K)
K
85
1936
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
2
Cleared 510(K)
K
85
3135
VISITEC 2 MICRON FLUID FILTER
2
Cleared 510(K)
K
85
2271
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
2
Cleared 510(K)
K
85
1610
COMBINED MVS SYSTEMS
2
Cleared 510(K)
K
85
1272
VERSAPHAGE
2
Cleared 510(K)
K
84
3594
AIRVIT MODEL 8500
2
Cleared 510(K)
K
85
0857
I/A HANDPIECE
2
Cleared 510(K)
K
84
4715
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
2
Cleared 510(K)
K
84
3391
INFUSION ASPIRATION VITRECTOMY SYS
2
Cleared 510(K)
K
84
2793
MVS XII
2
Cleared 510(K)
K
84
4510
OMS SCISSORS
2
Cleared 510(K)
K
84
4374
O.M.S. GUILLOTINE CUTTER
2
Cleared 510(K)
K
84
2188
MULTIPLE-LENS, SPECTACLES, CUSTOM
2
Cleared 510(K)
K
84
3041
HESLIN DISPOS. TUBING SET
2
Cleared 510(K)
K
84
2471
AUTOMATED INTRAOCULAR SCISSORS
2
Cleared 510(K)
K
84
1738
AMER. SURGICAL CORP. EXTRA PLUS PAK
2
Cleared 510(K)
K
84
2197
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG
2
Cleared 510(K)
K
83
4155
UNIVERSAL PACK
2
Cleared 510(K)
K
83
4437
KEATES IRRIGATION/ASPIRATION/VITREOUS
2
Cleared 510(K)
K
83
2703
ARGON LASER SYS-MODEL 5000
2
Cleared 510(K)
K
83
3371
DISPOSABLE OCUTOME PROBE
2
Cleared 510(K)
K
83
4163
ULTRAVIT
2
Cleared 510(K)
K
83
2446
CATAREX DIAP. EXTRACAPSULAR CATARACT
2
Cleared 510(K)
K
83
2235
DISPOSABLE VITRECTOMY HANDPIECE
2
Cleared 510(K)
K
83
1584
BAILEY ASPIRATOR/IRRIGATOR
2
Cleared 510(K)
K
83
0037
EXTENSION HANDLE FOR ACUTOME PROBE
2
Cleared 510(K)
K
83
0216
DORC COMPACT MICRO SURGICAL SYSTEM
2
Cleared 510(K)
K
82
2220
COOPER VISION I/A SYSTEM III MODEL 1500
2
Cleared 510(K)
K
82
0933
CILCO I/A HANDPIECE
2
Cleared 510(K)
K
82
0008
VERSATOME I
2
Cleared 510(K)
K
82
0026
VITRE CON
2
Cleared 510(K)
K
81
3274
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
2
Cleared 510(K)
K
81
2857
CHARLES MICRO PROBE
2
Cleared 510(K)
K
81
3500
OMS INFUSION-ASPIRATION HANDLE
2
Cleared 510(K)
K
81
3389
ULTRASONIC FRAGMENTOR
2
Cleared 510(K)
K
80
1850
CHARLES PNEUMATIC INTRAOCULAR SCISSORS
2
Cleared 510(K)
K
80
0110
X-FLO
2
Cleared 510(K)
K
79
1212
VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG
2
Cleared 510(K)
K
78
1471
PNEUMATIC VITRECTOMY CONTROL UNIT
2
Cleared 510(K)
K
77
1711
BIOTOME
2
Cleared 510(K)
HQF
Laser, Ophthalmic
2
Product Code
HQO
Unit, Cautery, Thermal, Ac-Powered
2
Product Code
HQP
Unit, Cautery, Thermal, Battery-Powered
2
Product Code
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
2
Product Code
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
2
Product Code
HQS
Burr, Corneal, Ac-Powered
1
Product Code
HRF
Engine, Trephine, Accessories, Battery-Powered
1
Product Code
HRG
Engine, Trephine, Accessories, Ac-Powered
1
Product Code
HRH
Trephine, Manual, Ophthalmic
1
Product Code
HRJ
Table, Instrument, Powered, Ophthalmic
1
Product Code
HRK
Table, Instrument, Manual, Ophthalmic
1
Product Code
HRN
Unit, Cryophthalmic, Ac-Powered
2
Product Code
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
2
Product Code
HRP
Pen, Marking, Surgical
1
Product Code
KYB
Lens, Guide, Intraocular
1
Product Code
KYG
Device, Irrigation, Ocular Surgery
1
Product Code
LCC
Applicator, Ocular Pressure
2
Product Code
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
3
Product Code
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
2
Product Code
LWL
Fluid, Intraocular
3
Product Code
LXP
Plug, Scleral
2
Product Code
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
2
Product Code
LZP
Aid, Surgical, Viscoelastic
3
Product Code
MLZ
Vitrectomy, Instrument Cutter
2
Product Code
MMC
Dilator, Expansive Iris (Accessory)
2
Product Code
MOE
Collagen Corneal Shield
1
Product Code
MSR
Tubing, Replacement, Phacofragmentation Unit
2
Product Code
MSS
Folders And Injectors, Intraocular Lens (Iol)
1
Product Code
MUS
Fluidic, Phacoemulsification/Phacofragmentation
2
Product Code
MXO
Laser, System, Phacolysis
2
Product Code
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
1
Product Code
MYD
Keratome, Water Jet
1
Product Code
NCE
Injector, Capsular Tension Ring
1
Product Code
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
2
Product Code
NGY
Cannula, Trocar, Ophthalmic
1
Product Code
NKX
Needle, Phacoemulsification, Reprocessed
2
Product Code
NKY
Blade, Keratome, Reprocessed
1
Product Code
NLA
Knife, Ophthalmic, Reprocessed
1
Product Code
NVB
Intraocular, Pressure Measuring Device
3
Product Code
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
1
Product Code
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
1
Product Code
OJK
Eye Tray
2
Product Code
OOE
Ophthalmic Femtosecond Laser
2
Product Code
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
1
Product Code
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
2
Product Code
PZG
Surgical Eye Tray
1
Product Code
QDV
Iol Tray
1
Product Code
QDW
Phaco Kit
2
Product Code
QDY
Vitrectomy Kit
2
Product Code
QGJ
Corneal Inlay Inserter Handle
1
Product Code
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
1
Product Code
PYU
Sponge, Eyelid Cleaning, Powered
1
Product Code
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 2 June 2023 at 11:04 pm
OP
/
surgical-devices
/
HQE
/
K850857
View Source
I/A HANDPIECE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K850857
510(k) Type
Traditional
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/1985
Days to Decision
28 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
Surgical Devices
HLD
Engine, Trephine, Accessories, Gas-Powered
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
FCT
Headlight, Fiberoptic Focusing
FSR
Light, Headband, Surgical
FTZ
Locator, Magnetic
HMQ
Marker, Sclera
HMR
Marker, Ocular
HMS
Drum, Eye Knife Test
HMX
Cannula, Ophthalmic
HMY
Keratome, Battery-Powered
HMZ
Trabeculotome
HNA
Spud, Ophthalmic
HNB
Spoon, Ophthalmic
HNC
Specula, Ophthalmic
HND
Spatula, Ophthalmic
HNE
Snare, Enucleating
HNF
Scissors, Ophthalmic
HNG
Rongeur, Lachrymal Sac
HNH
Ring, Ophthalmic (Flieringa)
HNI
Retractor, Ophthalmic
HNJ
Punch, Corneo-Scleral
HNK
Probe, Trabeculotomy
HNL
Probe, Lachrymal
HNM
Needle, Ophthalmic Suturing
HNN
Knife, Ophthalmic
HNO
Keratome, Ac-Powered
HNP
Introducer, Sphere
HNQ
Hook, Ophthalmic
HNR
Forceps, Ophthalmic
HNS
Expressor
HNT
Erisophake
HNW
Dilator, Lachrymal
HNX
Depressor, Orbital
HNY
Cystotome
HNZ
Curette, Ophthalmic
HOA
Compressor, Orbital
HOB
Clamp, Muscle, Ophthalmic
HOC
Clip, Iris Retractor
HOD
Clamp, Eyelid, Ophthalmic
HOE
Caliper, Ophthalmic
HOF
Burr, Corneal, Manual
HOG
Burr, Corneal, Battery-Powered
HOH
Spectacle, Operating (Loupe), Ophthalmic
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
HOZ
Sponge, Ophthalmic
HPM
Locator, Metal, Electronic
HPN
Magnet, Permanent
HPO
Magnet, Ac-Powered
HPP
Headlamp, Operating, Battery-Operated
HPQ
Headlamp, Operating, Ac-Powered
HPS
Unit, Cryophthalmic
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
HQA
Unit, Cryotherapy, Ophthalmic
HQB
Photocoagulator And Accessories
HQC
Unit, Phacofragmentation
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
K
17
0183
Cetus system, Cetus probe
K
15
3168
Bi-Blade Vitrectomy Cutter
K
14
1065
CONSTELLATION VISION SYSTEM
K
12
1675
VERSAVIT
K
12
0170
PROCARE PLUS VITRECTOMY SYSTEM
K
10
2222
ULTIMATE VIT ENHAMCER (UVE)
K
03
3390
COLIBRI DISPOSABLE VITRECTOMY CUTTER
K
03
0948
VMATE MODEL VMM1000
K
02
3939
VELOCITY ADVANTAGE
K
02
0911
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K
01
0082
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
K
99
2943
VIT ENHANCER
K
99
0292
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
K
98
3797
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
K
98
0400
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
K
98
0399
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
K
98
0488
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K
97
0670
REUSABLE VITRECTOMY PROBE
K
97
0673
DISPOSABLE VITRECTOMY PROBE
K
96
4743
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K
96
1738
VIT COMMANDER SYSTEM
K
96
0061
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K
96
1078
AUTOMATED VITRECTOMY DEVICE
K
95
4816
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
K
95
3576
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K
95
3575
STORZ MVS-3201 VITRECTOMY PROBE PACK
K
95
0852
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
K
95
0799
PRO-VIT
K
94
6135
INFINITECH ASPIRATING LASER PROBE
K
94
6181
INFINITECH SOFT TIP FLUTE NEEDLE
K
93
4600
MICRODRIVE
K
93
6302
NIDEK MODEL VT-4000, MODIFICATION
K
94
0391
PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
K
94
0746
VIT CUTTER MODEL 94
K
93
2669
SUPRA-VIT(TM)
K
93
0842
THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
K
93
3907
STORZ FIBEROPTIC PICK MANIPULATOR
K
93
2668
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
K
93
4204
INTERTIP INFUSION SET
K
93
3984
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K
93
3208
BARE-FIBER ENDOILLUMINATOR
K
92
4353
NIDEK MODEL VST-4000
K
92
4222
MID LABS, INC. VIT MATE
K
92
4604
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
K
92
2355
POLLY'S VITREOUS SCISSORS J-225-S
K
92
1758
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
K
92
1460
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
K
92
0718
DISPOSABLE POSTERIOR MICROSCISSORS
K
92
0582
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
K
91
5745
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K
91
3504
STORZ MICRO CUTTER 25 GAUGE PACK
K
91
3261
DWYER EYE SYSTEMS ASPIRATION UNIT
K
91
2384
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K
91
4038
POLLY'S CUTTER J-225
K
91
3837
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
K
91
4221
KPE 220 TS, NONSTERILE
K
91
2253
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
K
91
1998
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
K
91
0973
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
K
90
4909
I/A VITROPHAGE MODEL YPR 2001
K
89
5813
GLAUCOMA MECHANICAL TREPHINE
K
89
6943
SITE DISPOSABLE CUTTER AND ACCESSORIES
K
89
4248
CONVERTER SYSTEM
K
89
6754
I/A HANDPIECE
K
89
6305
MULTI-USE I/A HANDPIECE
K
89
4278
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K
89
0195
JAMES SURGICAL SYSTEM J1000
K
89
1601
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K
88
4557
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K
89
0622
SURG-E-TROL SYSTEM I AND SYSTEM II
K
89
0300
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K
89
0133
OCULAR CONNECTION MACHINE(TM)
K
89
0544
SHAPIRO CUTTER
K
88
4556
DREYER CURVED ENDOILLUMINATOR
K
88
5196
LASER INDIRECT OPHTHALMOSCOPE (LIO)
K
88
4043
GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
K
88
3926
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
K
88
3975
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
K
88
3605
MODIFIED REUSABLE SITE FIBER OPTIC CABLE
K
88
1519
VAC-G (GUILLOTINE VITRECTOR)
K
88
1520
VAC (OSCILLATING VITRECTOR)
K
88
0943
MICROLINE CAT #100
K
88
1927
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K
88
0929
NIDEK CV-4000
K
88
0968
MODEL 2001 PHACOEMULSIFIER ASPIRATOR
K
87
2312
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
K
87
1871
SERIES TEN THOUSAND OCUTOME
K
87
1375
SITE PERISTALTIC MODULE SYSTEM
K
87
0775
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
K
87
0068
ASPIRATION REVERSAL CONTROL (ARC) MODULE
K
86
4035
VES-10 INTRAOCULAR SCISSORS DRIVE
K
86
2943
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K
86
2188
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
K
86
2343
VACUUM HANDLE MODEL I/A - 1
K
86
1565
SERIES TEN THOUSAND COMPACT
K
86
1380
SERIES TEN THOUSAND MASTER
K
86
0891
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
K
86
0014
SYSTEMS PLUS
K
85
4868
I/A - VFE SYSTEM II
K
85
4871
MICRO SURGICAL SYSTEM
K
83
4162
VIT PAC
K
83
4160
VITREONIC PLUS
K
85
4508
STORZ DAISY
K
85
3430
STORZ IAS DISPOSABLE PACK
K
85
3961
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K
85
3457
COBURN I/A SYSTEM
K
85
3382
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
K
85
3308
KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
K
85
1936
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
K
85
3135
VISITEC 2 MICRON FLUID FILTER
K
85
2271
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K
85
1610
COMBINED MVS SYSTEMS
K
85
1272
VERSAPHAGE
K
84
3594
AIRVIT MODEL 8500
K
85
0857
I/A HANDPIECE
K
84
4715
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K
84
3391
INFUSION ASPIRATION VITRECTOMY SYS
K
84
2793
MVS XII
K
84
4510
OMS SCISSORS
K
84
4374
O.M.S. GUILLOTINE CUTTER
K
84
2188
MULTIPLE-LENS, SPECTACLES, CUSTOM
K
84
3041
HESLIN DISPOS. TUBING SET
K
84
2471
AUTOMATED INTRAOCULAR SCISSORS
K
84
1738
AMER. SURGICAL CORP. EXTRA PLUS PAK
K
84
2197
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG
K
83
4155
UNIVERSAL PACK
K
83
4437
KEATES IRRIGATION/ASPIRATION/VITREOUS
K
83
2703
ARGON LASER SYS-MODEL 5000
K
83
3371
DISPOSABLE OCUTOME PROBE
K
83
4163
ULTRAVIT
K
83
2446
CATAREX DIAP. EXTRACAPSULAR CATARACT
K
83
2235
DISPOSABLE VITRECTOMY HANDPIECE
K
83
1584
BAILEY ASPIRATOR/IRRIGATOR
K
83
0037
EXTENSION HANDLE FOR ACUTOME PROBE
K
83
0216
DORC COMPACT MICRO SURGICAL SYSTEM
K
82
2220
COOPER VISION I/A SYSTEM III MODEL 1500
K
82
0933
CILCO I/A HANDPIECE
K
82
0008
VERSATOME I
K
82
0026
VITRE CON
K
81
3274
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
K
81
2857
CHARLES MICRO PROBE
K
81
3500
OMS INFUSION-ASPIRATION HANDLE
K
81
3389
ULTRASONIC FRAGMENTOR
K
80
1850
CHARLES PNEUMATIC INTRAOCULAR SCISSORS
K
80
0110
X-FLO
K
79
1212
VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG
K
78
1471
PNEUMATIC VITRECTOMY CONTROL UNIT
K
77
1711
BIOTOME
HQF
Laser, Ophthalmic
HQO
Unit, Cautery, Thermal, Ac-Powered
HQP
Unit, Cautery, Thermal, Battery-Powered
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
HQS
Burr, Corneal, Ac-Powered
HRF
Engine, Trephine, Accessories, Battery-Powered
HRG
Engine, Trephine, Accessories, Ac-Powered
HRH
Trephine, Manual, Ophthalmic
HRJ
Table, Instrument, Powered, Ophthalmic
HRK
Table, Instrument, Manual, Ophthalmic
HRN
Unit, Cryophthalmic, Ac-Powered
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
HRP
Pen, Marking, Surgical
KYB
Lens, Guide, Intraocular
KYG
Device, Irrigation, Ocular Surgery
LCC
Applicator, Ocular Pressure
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
LWL
Fluid, Intraocular
LXP
Plug, Scleral
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
LZP
Aid, Surgical, Viscoelastic
MLZ
Vitrectomy, Instrument Cutter
MMC
Dilator, Expansive Iris (Accessory)
MOE
Collagen Corneal Shield
MSR
Tubing, Replacement, Phacofragmentation Unit
MSS
Folders And Injectors, Intraocular Lens (Iol)
MUS
Fluidic, Phacoemulsification/Phacofragmentation
MXO
Laser, System, Phacolysis
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
MYD
Keratome, Water Jet
NCE
Injector, Capsular Tension Ring
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
NGY
Cannula, Trocar, Ophthalmic
NKX
Needle, Phacoemulsification, Reprocessed
NKY
Blade, Keratome, Reprocessed
NLA
Knife, Ophthalmic, Reprocessed
NVB
Intraocular, Pressure Measuring Device
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
OJK
Eye Tray
OOE
Ophthalmic Femtosecond Laser
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
PZG
Surgical Eye Tray
QDV
Iol Tray
QDW
Phaco Kit
QDY
Vitrectomy Kit
QGJ
Corneal Inlay Inserter Handle
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
PYU
Sponge, Eyelid Cleaning, Powered
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
surgical-devices
/
HQE
/
K850857
View Source
I/A HANDPIECE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K850857
510(k) Type
Traditional
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/1985
Days to Decision
28 days