Product code HNN
- Device name
- Knife, 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 |
|---|---|---|---|
| K110166 | CLEARCUT S SAFETY KNIFE | Alcon Research, Ltd. | 2011-05-20 |
| K922378 | OPHTHALMIC KNIFE | Microptics Development Laboratory | 1992-12-10 |
| K882402 | RETRACTIVE INCISION MICROMETER (RIM) GUAGE | Optical Center | 1988-08-22 |
| K881669 | MVR/STILETTO BLADE 20GA. - P/N 1900 | Advanced Surgical Products, Inc. | 1988-05-13 |
| K874979 | PRISMA DISPOSABLE MVR/STILETTO BLADE | Advanced Surgical Products, Inc. | 1988-04-13 |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Myocure, Inc. | 1987-12-23 |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Myocure, Inc. | 1987-12-22 |
| K873385 | OPHTHALMIC PHACO-BLADE | Myocure, Inc. | 1987-09-21 |
| K871285 | KNIFE, OPHTHALMIC | Trueline Instruments, Inc. | 1987-04-27 |
| K864290 | RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE | Keeler Instruments, Inc. | 1986-12-15 |
| K863725 | CATARACT DIAMOND KNIFE | Medical Technology Development Corp. | 1986-10-31 |
| K863665 | THE ULTIMATE | Myocure, Inc. | 1986-09-25 |
| K861744 | SAPPHIRE KNIFE BLADE | Keeler Instruments, Inc. | 1986-06-09 |
| K861748 | RUBY & SAPPHIRE BLADE HOLDER | Keeler Instruments, Inc. | 1986-06-02 |
| K861732 | STORZ E9050 & E9055 DIAMOND KNIVES | Storz Instrument Co. | 1986-05-28 |
| K861491 | ROPHAE DIAMOND KNIFE | Rophae Lens Co., Inc. | 1986-05-28 |
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | Cilco, Inc. | 1986-05-02 |
| K860852 | SAPPHIRE BLADE SURGICAL KNIFE | Med-Tech Develoment Corp. | 1986-03-28 |
| K855050 | STORZ E9040 & E9046 DIAMOND KNIVES | Storz Instrument Co. | 1986-03-05 |
| K860332 | DIAMOND BLADE MICROMETER KNIFE | Med-Tech Develoment Corp. | 1986-02-13 |
| K860331 | DISPOSABLE SURGICAL KNIFE | Med-Tech Develoment Corp. | 1986-02-12 |
| K860305 | BEAVER MICRO-GEM GAUGE BLOCK | Rudolph Beaver, Inc. | 1986-02-12 |
| K853598 | OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE | Myocure, Inc. | 1985-11-04 |
| K853403 | STORZ DIAMOND KNIFE | Storz Instrument Co. | 1985-11-04 |
| K853063 | SMARTKNIFE SYSTEM | CooperVision, Inc. | 1985-11-04 |
| K852828 | BEAVER R-K KNIFE | Rudolph Beaver, Inc. | 1985-11-04 |
| K852633 | VERSABLADE | Alphamedix, Inc. | 1985-11-04 |
| K852706 | VERSABLADE | Alphamedix, Inc. | 1985-11-04 |
| K853499 | MICRON-SCOPE | Magnum Diamond, Inc. | 1985-09-24 |
| K853129 | BEAVER MULTIPURPOSE SAPPHIRE KNIFE | Rudolph Beaver, Inc. | 1985-08-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08052276033482 | Phaco Slit Knife 1.2 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033628 | Phaco Slit Knife 2.2 mm Dual Bevel Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033611 | Phaco Slit Knife 2.2 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033604 | Phaco Slit Knife 2.2 mm Bevel Up Angled | AKTIVE SRL | 2024-01-15 |
| 08052276033598 | Phaco Slit Knife 2.0 mm Dual Bevel Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033581 | Phaco Slit Knife 2.0 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033574 | Phaco Slit Knife 2.0 mm Bevel Up Angled | AKTIVE SRL | 2024-01-15 |
| 08052276033567 | Phaco Slit Knife 1.8 mm Dual Bevel Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033550 | Phaco Slit Knife 1.8 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033543 | Phaco Slit Knife 1.8 mm Bevel Up Angled | AKTIVE SRL | 2024-01-15 |
| 08052276033536 | Phaco Slit Knife 1.6 mm Dual Bevel Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033529 | Phaco Slit Knife 1.6 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033512 | Phaco Slit Knife 1.4 mm Dual Bevel Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033505 | Phaco Slit Knife 1.4 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276033499 | Phaco Slit Knife 1.2 mm Dual Bevel Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276029683 | Crescent Knife 2.0 mm Bevel Up Straight with protection | AKTIVE SRL | 2024-01-15 |
| 08052276029676 | Crescent Knife 2.0 mm Bevel Up Straight | AKTIVE SRL | 2024-01-15 |
| 08052276029669 | Crescent Knife 2.0 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276029652 | Crescent Knife 2.0 mm Bevel Up Angled | AKTIVE SRL | 2024-01-15 |
| 08052276029645 | Crescent Knife 1.2 mm Bevel Up Angled with protection | AKTIVE SRL | 2024-01-15 |
| 08052276019592 | Scleral blade 25G | AKTIVE SRL | 2024-01-11 |
| 08052276019578 | Scleral blade 23G | AKTIVE SRL | 2024-01-11 |
| 08052276019554 | Scleral blade 20G | AKTIVE SRL | 2024-01-11 |
| 08052276019530 | Scleral blade 19G | AKTIVE SRL | 2024-01-08 |
| 08052276019516 | Scleral blade 27G | AKTIVE SRL | 2024-01-08 |
| 07612717000155 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2022-06-15 |
| 07612717000032 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2020-08-19 |
| 07612717000193 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2020-08-19 |
| 07612717000186 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2020-08-19 |
| 07612717000063 | Alcon Grieshaber | Alcon Laboratories, Inc. | 2020-08-19 |