Prisma Dispos. Bishop-Harmon Irrigating Cannula
FDA 510(k) K874972 · Advanced Surgical Products, Inc.
510(k) numberK874972
Submission
- Device name
- Prisma Dispos. Bishop-Harmon Irrigating Cannula
- 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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| 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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| K890398 | Ryan-Style Directed Infusion ManipulatorHBI · Traditional | 02/17/1989SE |
| K884347 | Modified Disposable Coaxial Bipolar PenGXI · Traditional | 12/27/1988SE |
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Questions and answers
When was Prisma Dispos. Bishop-Harmon Irrigating Cannula cleared by the FDA?
Prisma Dispos. Bishop-Harmon Irrigating Cannula (K874972) 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 K874972?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.