Irrigator/Aspirator Probe
FDA 510(k) K915074 · Biomedical Dynamics, Inc.
510(k) numberK915074
Submission
- Device name
- Irrigator/Aspirator Probe
- Applicant
- Biomedical Dynamics, Inc.
Burnsville, MN, US - Received
- November 8, 1991
- Decision date
- February 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
| K901618 | Ocular Infusion Cannula SystemHMX · Traditional | Tamcenan Corp. | 05/31/1990SE |
More from Tamcenan Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K913751 | Pressure InfuserKZD · Traditional | 01/09/1992SE |
| K911213 | CuffableDXQ · Traditional | 08/07/1991SE |
| K911216 | InfusableKZD · Traditional | 07/22/1991SE |
| K911324 | Irrigation/Aspiration Tubing SetKDH · Traditional | 06/24/1991SE |
| K904376 | Aneroid Blood Pressure GaugeFCY · Traditional | 12/20/1990SE |
| K890268 | Pressure Infusor for I.V. Bags/AutoinflationKPE · Traditional | 05/05/1989SE |
| K881799 | Blood Pressure CuffDXQ · Traditional | 10/14/1988SE |
| K861977 | Biomedical Dynamics Disposable Pressure InfusorKZD · Traditional | 07/15/1986SE |
| K850506 | Correct Flo Intravascular Administration SetFPA · Traditional | 04/01/1985SE |
Questions and answers
When was Irrigator/Aspirator Probe cleared by the FDA?
Irrigator/Aspirator Probe (K915074) received a 510(k) decision of Substantially Equivalent on February 5, 1992, 89 days after the submission was received.
What is the product code of K915074?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.