The New Mobile Tip Mcintyre Cannula
FDA 510(k) K854401 · Microsurgical Technology, Inc.
510(k) numberK854401
Submission
- Device name
- The New Mobile Tip Mcintyre Cannula
- Applicant
- Microsurgical Technology, Inc.
Kirkland, WA, US - Received
- October 31, 1985
- Decision date
- December 30, 1985
- 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 |
|---|---|---|
| K953959 | Phaco Handpiece for Phaco Fragmentation Machines, Phaco Sleeve for Attachment to Phaco…HQC · Traditional | 11/17/1995SE |
| K946194 | Wee Bag O'MercuryLCC · Traditional | 02/27/1995SE |
| K943672 | Phaco Needles and TipsHQC · Traditional | 10/13/1994SE |
| K942403 | Infusion CannulaHMX · Traditional | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | 04/19/1994SE |
| K854402 | The New Mcintyre I.A. HandpieceHMX · Traditional | 12/30/1985SE |
| K853777 | The New Mcintyre CannulaHMX · Traditional | 11/21/1985SE |
| K840442 | Sterilized Dispos. CystotomeHMX · Traditional | 03/16/1984SE |
Questions and answers
When was The New Mobile Tip Mcintyre Cannula cleared by the FDA?
The New Mobile Tip Mcintyre Cannula (K854401) received a 510(k) decision of Substantially Equivalent on December 30, 1985, 60 days after the submission was received.
What is the product code of K854401?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.