Ophthalmic Phaco-Blade
FDA 510(k) K873385 · Myocure, Inc.
510(k) numberK873385
Submission
- Device name
- Ophthalmic Phaco-Blade
- Applicant
- Myocure, Inc.
Glendale, CA, US - Received
- August 24, 1987
- Decision date
- September 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNN – Knife, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | Alcon Research, Ltd. | 05/20/2011SE |
| K922378 | Ophthalmic KnifeHNN · Traditional | Microptics Development Laboratory | 12/10/1992SE |
| K882402 | Retractive Incision Micrometer (Rim) GuageHNN · Traditional | Optical Center | 08/22/1988SE |
| K881669 | Mvr/Stiletto Blade 20GA. - P/N 1900HNN · Traditional | Advanced Surgical Products, Inc. | 05/13/1988SE |
| K874979 | Prisma Disposable Mvr/Stiletto BladeHNN · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874057 | Ophthalmic Tip & Blade ScalpelsHNN · Traditional | Myocure, Inc. | 12/23/1987SE |
| K874056 | Ophthalmic Disposable BladesHNN · Traditional | Myocure, Inc. | 12/22/1987SE |
| K871285 | Knife, OphthalmicHNN · Traditional | Trueline Instruments, Inc. | 04/27/1987SE |
| K864290 | Rk-M & Rk-Dk Diamond Knives with Measuring GaugeHNN · Traditional | Keeler Instruments, Inc. | 12/15/1986SE |
| K863725 | Cataract Diamond KnifeHNN · Traditional | Medical Technology Development Corp. | 10/31/1986SE |
More from Medical Technology Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K880347 | Anesthesia/Retrobulbar NeedlesHMX · Traditional | 05/03/1988SE |
| K880346 | CannulasHMX · Traditional | 05/03/1988SE |
| K880345 | Cystotomes/KnifesHNY · Traditional | 05/03/1988SE |
| K874057 | Ophthalmic Tip & Blade ScalpelsHNN · Traditional | 12/23/1987SE |
| K874056 | Ophthalmic Disposable BladesHNN · Traditional | 12/22/1987SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | 11/17/1986SE |
| K863666 | The Saver Kit · Traditional | 10/20/1986SE |
| K863663 | Ophthalmic Surgical Ocular MarkersHMR · Traditional | 10/20/1986SE |
| K863662 | Ophthalmic Surgical Drape · Traditional | 10/20/1986SE |
| K863665 | The UltimateHNN · Traditional | 09/25/1986SE |
Questions and answers
When was Ophthalmic Phaco-Blade cleared by the FDA?
Ophthalmic Phaco-Blade (K873385) received a 510(k) decision of Substantially Equivalent on September 21, 1987, 28 days after the submission was received.
What is the product code of K873385?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.