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 |
| K875030 | OCU-1 | Rudolph Beaver, Inc. | 1988-05-03 |
| K880346 | CANNULAS | Myocure, Inc. | 1988-05-03 |
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | Myocure, Inc. | 1988-05-03 |
| K881487 | OPHTHALMIC CANNULA | Surgical Instrument, Inc. | 1988-04-29 |
| K874968 | PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874969 | PRISMA DISPOSABLE KRATZ CAPSULE POLISHER | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874970 | PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874971 | PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874972 | PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874973 | PRISMA DISPOSABLE SIMCOE I/A 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860015282040 | Intrace USA | PILOTIS TECH LLC | 2026-07-03 |
| 00840285320796 | Walcott Rx Products | Walcott Rx Product Inc | 2026-06-26 |
| 00840319759189 | Hayden Medical | Hayden Medical, Inc. | 2026-06-24 |
| 04251047903755 | Nagahara Phaco-Chopper | A1 Medical GmbH | 2026-06-09 |
| 04251047903632 | Chang Phaco Chopper | A1 Medical GmbH | 2026-06-09 |
| 04251047903175 | Nagahara Phaco-Chopper | A1 Medical GmbH | 2026-06-09 |
| 04251047903151 | Nagahara Phaco-Chopper | A1 Medical GmbH | 2026-06-09 |
| 04251047923296 | Rycroft Air Injection Cannula | A1 Medical GmbH | 2026-05-29 |
| 04251047915086 | Akahoshi Combo Pre-Chopper | A1 Medical GmbH | 2026-05-29 |
| 10817489026509 | 23ga Subretinal Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026516 | 25ga Subretinal Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026523 | 20ga Dual Bore PFC Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026530 | 27ga Subretinal Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026547 | 23ga Dual Bore PFC Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026554 | 25ga Dual Bore PFC Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026561 | 27ga Dual Bore PFC Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489026493 | 20ga Subretinal Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10817489027568 | 20ga Mason Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 10840096211099 | 27ga Mason Cannula | KATALYST SURGICAL LLC | 2020-11-14 |
| 00840096208412 | Replacement Backflush Reservoir, Active Handpiece | KATALYST SURGICAL LLC | 2020-06-11 |
| 00840096208429 | Titanium Backflush Handpiece, Passive Aspiration | KATALYST SURGICAL LLC | 2020-06-11 |
| 00840096208436 | Replacement Backflush Reservoir, Passive Handpiece | KATALYST SURGICAL LLC | 2020-06-11 |
| 00840096208405 | Titanium Backflush Handpiece, Active Aspiration | KATALYST SURGICAL LLC | 2020-06-11 |
| 10840096211518 | 23ga Awh MVP™ Micro Vacuum Pick™ Disposable Cannula | KATALYST SURGICAL LLC | 2020-03-30 |
| 10840096211525 | 27ga Awh MVP™ Micro Vacuum Pick™ Disposable Cannula | KATALYST SURGICAL LLC | 2020-03-30 |
| 00840096205282 | 27ga Reusable Maeno-Awh Super Manipulator | KATALYST SURGICAL LLC | 2019-08-12 |
| 00840096205275 | 25ga Reusable Maeno-Awh Super Manipulator | KATALYST SURGICAL LLC | 2019-08-12 |
| 10817489027452 | 20ga Maeno-Awh Super Manipulator | KATALYST SURGICAL LLC | 2019-02-20 |
| 10817489027377 | 25ga Mason Cannula | KATALYST SURGICAL LLC | 2018-10-08 |
| 10817489027360 | 23ga Mason Cannula | KATALYST SURGICAL LLC | 2018-10-08 |