Ophthalmic Surgical Ocular Markers
FDA 510(k) K863663 · Myocure, Inc.
510(k) numberK863663
Submission
- Device name
- Ophthalmic Surgical Ocular Markers
- Applicant
- Myocure, Inc.
Glendale, CA, US - Received
- September 18, 1986
- Decision date
- October 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMR – Marker, Ocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4570
- Specialty
- Ophthalmic
Other 510(k)s with product code HMR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053475 | Optipoint Corneal Marker, Model VPT-OPT-450HMR · Traditional | Refractec, Inc. | 03/03/2006SE |
| K925606 | Optical Zone/Hexagonal/Astigmatism/Radial MarkersHMR · Traditional | Chiron Vision Corp. | 08/29/1994SE |
| K872747 | Laser Centering DeviceHMR · Traditional | Innomed Corp. | 09/04/1987SE |
| K861535 | Optical Markers/Fixation Ring/Cannu & Irriga CannuHMR · Traditional | CooperVision, Inc. | 05/14/1986SE |
More from CooperVision, Inc.
| 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 |
| K873385 | Ophthalmic Phaco-BladeHNN · Traditional | 09/21/1987SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | 11/17/1986SE |
| K863666 | The Saver Kit · 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 Surgical Ocular Markers cleared by the FDA?
Ophthalmic Surgical Ocular Markers (K863663) received a 510(k) decision of Substantially Equivalent on October 20, 1986, 32 days after the submission was received.
What is the product code of K863663?
The FDA product code is HMR – Marker, Ocular, a Class I (low risk) device regulated under 21 CFR 886.4570.