Aspirating Endo Ocular Probe W/Illumination
FDA 510(k) K921488 · Surgical Technologies, Inc.
510(k) numberK921488
Submission
- Device name
- Aspirating Endo Ocular Probe W/Illumination
- Applicant
- Surgical Technologies, Inc.
Chesterfield, MO, US - Received
- March 30, 1992
- Decision date
- May 7, 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
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|---|---|---|---|
| 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 |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| 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 |
|---|---|---|
| K941992 | CystoscopeFBO · Traditional | 11/30/1995SE |
| K942029 | ArthroscopeHRX · Traditional | 11/08/1995SE |
| K946136 | Infinitech Lighted Infusion CannulaMPA · Traditional | 10/02/1995SE |
| K952566 | OscilflatorMAV · Traditional | 08/31/1995SE |
| K951918 | Surgical Technologies, Inc. SyringeFMF · Traditional | 07/20/1995SE |
| K950683 | Arthrogram TrayJAA · Traditional | 05/06/1995SE |
| K946135 | Infinitech Aspirating Laser ProbeHQE · Traditional | 04/18/1995SE |
| K946181 | Infinitech Soft Tip Flute NeedleHQE · Traditional | 03/14/1995SE |
| K942030 | Biopsy ScissorsOCZ · Traditional | 06/27/1994SE |
| K942482 | Pressure Monitoring ExtensionDQO · Traditional | 06/14/1994SE |
Questions and answers
When was Aspirating Endo Ocular Probe W/Illumination cleared by the FDA?
Aspirating Endo Ocular Probe W/Illumination (K921488) received a 510(k) decision of Substantially Equivalent on May 7, 1992, 38 days after the submission was received.
What is the product code of K921488?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.