Cannulas
FDA 510(k) K880346 · Myocure, Inc.
510(k) numberK880346
Submission
- Device name
- Cannulas
- Applicant
- Myocure, Inc.
Glendale, CA, US - Received
- January 26, 1988
- Decision date
- May 3, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMX – Cannula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010305 | Weiss Retinal CannulaHMX · Traditional | Micron Surgical, Inc. | 05/02/2001SE |
| K000457 | Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional | Retinalabs.Com | 05/09/2000SE |
| K970873 | Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K943932 | Steriseal Ophthalmic CannulaHMX · Traditional | Pharma-Plast, Ltd. | 01/18/1995SE |
| K942403 | Infusion CannulaHMX · Traditional | Microsurgical Technology, Inc. | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | Microsurgical Technology, Inc. | 04/19/1994SE |
| K930113 | Kirwan Irrigation/Aspiration HandpieceHMX · Traditional | Kirwan Surgical Products, Inc. | 02/17/1994SE |
| K921488 | Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional | Surgical Technologies, Inc. | 05/07/1992SE |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
More from Visitec Co.
| 510(k) | Device | Decision |
|---|---|---|
| K880347 | Anesthesia/Retrobulbar NeedlesHMX · 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 |
| 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 Cannulas cleared by the FDA?
Cannulas (K880346) received a 510(k) decision of Substantially Equivalent on May 3, 1988, 98 days after the submission was received.
What is the product code of K880346?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.