Product code HMX
- Device name
- Cannula, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010305 | WEISS RETINAL CANNULA | Micron Surgical, Inc. | 2001-05-02 |
| K000457 | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES | Retinalabs.Com | 2000-05-09 |
| K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | American Medical Devices, Inc. | 1997-05-20 |
| K943932 | STERISEAL OPHTHALMIC CANNULA | Pharma-Plast, Ltd. | 1995-01-18 |
| K942403 | INFUSION CANNULA | Microsurgical Technology, Inc. | 1994-08-17 |
| K934844 | INTER TIP T | Microsurgical Technology, Inc. | 1994-04-19 |
| K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE | Kirwan Surgical Products, Inc. | 1994-02-17 |
| K921488 | ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION | Surgical Technologies, Inc. | 1992-05-07 |
| K915074 | IRRIGATOR/ASPIRATOR PROBE | Biomedical Dynamics, Inc. | 1992-02-05 |
| K904074 | VITREORETINAL INFUSION CANNULA | Visitec Co. | 1991-02-26 |
| K901618 | OCULAR INFUSION CANNULA SYSTEM | Tamcenan Corp. | 1990-05-31 |
| K890782 | GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) | Grieshaber & Co. | 1989-06-23 |
| K882884 | STORZ INFUSION CANNULA | Storz Instrument Co. | 1988-08-04 |
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | Myocure, Inc. | 1988-05-03 |
| K875030 | OCU-1 | Rudolph Beaver, Inc. | 1988-05-03 |
| K880346 | CANNULAS | Myocure, Inc. | 1988-05-03 |
| K881487 | OPHTHALMIC CANNULA | Surgical Instrument, Inc. | 1988-04-29 |
| K874973 | PRISMA DISPOSABLE SIMCOE I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874972 | PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874974 | PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874977 | PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874978 | PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874980 | PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874981 | PRISMA DISPOSABLE J-SHAPED I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874982 | PRISMA DISPOSABLE SIMCOE EXTRACTOR | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874984 | PRISMA DISPOSABLE MICRO IRRIGATING VECTUS | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874986 | PRISMA DISPOSABLE RETROBULBAR NEEDLE | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874987 | PRISMA DISPOSABLE DOUBLE I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874999 | PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874996 | PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA. | Advanced Surgical Products, Inc. | 1988-04-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07612717072107 | FINESSE ModifEYE | Alcon Laboratories, Inc. | 2024-09-26 |
| 07612717072091 | FINESSE ModifEYE | Alcon Laboratories, Inc. | 2024-09-26 |
| 07612717072060 | FINESSE ModifEYE | Alcon Laboratories, Inc. | 2024-09-25 |
| 07612717072077 | FINESSE ModifEYE | Alcon Laboratories, Inc. | 2024-09-25 |
| 08052276012005 | Open End Curved Irrigation Cannula 23G with 3 lateral holes | AKTIVE SRL | 2023-12-19 |
| 08052276011992 | Needle 30G x 12,7 mm | AKTIVE SRL | 2023-12-19 |
| 08052276011985 | Cortex Extractor Cannula Simcoe 13 mm | AKTIVE SRL | 2023-12-19 |
| 08052276010469 | Nucleus Hydrodissection Cannula 27G x 22 mm- Curved Horizontal | AKTIVE SRL | 2023-12-19 |
| 08052276010414 | Nucleus Hydrodissection Cannula Ang. 35° 27G x 22 mm | AKTIVE SRL | 2023-12-19 |
| 08052276010513 | Anterior Chamber Cannula Rycroft 27G X 22mm | AKTIVE SRL | 2023-11-29 |
| 07640123277724 | Coaxial I/A 4520P | Medicel AG | 2021-09-08 |
| 07640123277731 | Coaxial I/A 4521P | Medicel AG | 2021-09-08 |
| 07640123277748 | Coaxial I/A 6520T | Medicel AG | 2021-09-08 |
| 07640123277755 | Coaxial I/A 4523P | Medicel AG | 2021-09-08 |
| 07640123277779 | Bimanual I/A CR23 | Medicel AG | 2021-09-08 |
| 07640123277786 | Coaxial I/A 4521ST | Medicel AG | 2021-09-08 |
| 07630055253378 | 23G IRRIGATION HANDPIECE | Medicel AG | 2021-05-10 |
| 07640123272101 | Swiss Coaxial I/A | Medicel AG | 2021-01-19 |
| 07640123272149 | Swiss Coaxial I/A | Medicel AG | 2021-01-19 |
| 07640123272132 | Swiss Coaxial I/A | Medicel AG | 2021-01-19 |
| 07612717071414 | Alcon Grieshaber 27+ | Alcon Laboratories, Inc. | 2020-08-18 |
| 07612717071407 | Alcon Grieshaber 27+ | Alcon Laboratories, Inc. | 2020-08-18 |
| 07612717064614 | Alcon Grieshaber UltraFlow | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717071216 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717071209 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717071193 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717071186 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717071179 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717071162 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2016-09-24 |
| 07612717065536 | Alcon Grieshaber UltraFlow | Alcon Laboratories, Inc. | 2016-09-24 |