Prisma Disposable Simcoe Capsule Polisher
FDA 510(k) K874974 · Advanced Surgical Products, Inc.
510(k) numberK874974
Submission
- Device name
- Prisma Disposable Simcoe Capsule Polisher
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- December 2, 1987
- Decision date
- April 13, 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
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| 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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| K896305 | Multi-Use I/A HandpieceHQE · Traditional | 12/18/1989SE |
| K884557 | Advanced Surgical Products Scissors HandpieceHQE · Traditional | 05/12/1989SE |
| K884556 | Dreyer Curved EndoilluminatorHQE · Traditional | 02/28/1989SE |
| K890398 | Ryan-Style Directed Infusion ManipulatorHBI · Traditional | 02/17/1989SE |
| K884347 | Modified Disposable Coaxial Bipolar PenGXI · Traditional | 12/27/1988SE |
| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
| K883857 | Fiberoptic Wire Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Prisma Disposable Simcoe Capsule Polisher cleared by the FDA?
Prisma Disposable Simcoe Capsule Polisher (K874974) received a 510(k) decision of Substantially Equivalent on April 13, 1988, 133 days after the submission was received.
What is the product code of K874974?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.