Multi-Use I/A Handpiece
FDA 510(k) K896305 · Advanced Surgical Products, Inc.
510(k) numberK896305
Submission
- Device name
- Multi-Use I/A Handpiece
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- October 30, 1989
- Decision date
- December 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030926 | Fast Throw Stainless Steel Surgical SutureFZP · Traditional | 07/21/2003SE |
| K895800 | Advanced Surgical Solid State Bipolar CoagulatorHQR · Traditional | 01/22/1990SE |
| K896754 | I/A HandpieceHQE · Traditional | 01/11/1990SE |
| 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 |
| K883856 | Fiberoptic Blunt Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Multi-Use I/A Handpiece cleared by the FDA?
Multi-Use I/A Handpiece (K896305) received a 510(k) decision of Substantially Equivalent on December 18, 1989, 49 days after the submission was received.
What is the product code of K896305?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.