Opthalmic Surgical Instruments
FDA 510(k) K860744 · Tridak Division of Indicon, Inc.
510(k) numberK860744
Submission
- Device name
- Opthalmic Surgical Instruments
- Applicant
- Tridak Division of Indicon, Inc.
Pearl River, NY, US - Received
- February 27, 1986
- Decision date
- March 31, 1986
- 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 |
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| K891007 | Nonimplanted Electrical Continence DeviceKPI · Traditional | 06/07/1990SE |
| K853059 | Laborie Fiberoptic Pressure Sensor & InterfaceFAP · Traditional | 01/10/1986SE |
| K852856 | Laborie Urodynamics ProcessorFAP · Traditional | 10/17/1985SE |
| K851934 | Cytological Cervical Spatula the Multi-SpatulaHHT · Traditional | 07/05/1985SE |
| K842609 | R.L. Medical Twin Light SourceFCW · Traditional | 08/09/1984SE |
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Questions and answers
When was Opthalmic Surgical Instruments cleared by the FDA?
Opthalmic Surgical Instruments (K860744) received a 510(k) decision of Substantially Equivalent on March 31, 1986, 32 days after the submission was received.
What is the product code of K860744?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.