Disposable & Resuable Irrigation/Aspiration Handpiece
FDA 510(k) K945171 · Boston Surgical Products, Inc.
510(k) numberK945171
Submission
- Device name
- Disposable & Resuable Irrigation/Aspiration Handpiece
- Applicant
- Boston Surgical Products, Inc.
Kingston, MA, US - Received
- October 21, 1994
- Decision date
- February 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
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| K003036 | Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional | Retinalabs.Com | 12/22/2000SE |
| K993591 | Bladeworks Disposable Alk TubingKYG · Traditional | Blade Works, Inc. | 12/28/1999SE |
| K981116 | Sovereign Cataract Extraction SystemKYG · Traditional | Allergan, Inc. | 05/19/1998SE |
| K980647 | Eye Irrigator Model #2020KYG · Traditional | Eye-Deal Ocular Safety Products, Inc. | 05/15/1998SE |
| K974561 | Moistair Fluid Air Tubing SetKYG · Traditional | American Medical Devices, Inc. | 02/19/1998SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 05/22/1997SE |
| K970161 | Hedges Corneal Wetting PakKYG · Traditional | Hedges Cwp, Inc. | 03/25/1997SE |
| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | Dutch Ophthalmic USA, Inc. | 04/15/1996SE |
| K940392 | Peregrine Pic MinipulatorKYG · Traditional | Peregrine Surgical , Ltd. | 08/23/1994SE |
More from Peregrine Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K972311 | Model 20 Bipolar CoagulatorGEI · Traditional | 09/18/1997SE |
| K972350 | Model 50 Bipolar CoagulatorGEI · Traditional | 08/21/1997SE |
| K944947 | Electrosurgical Cutting & Coagulation Device & AccessGEI · Traditional | 07/28/1995SE |
| K953012 | Disposable & Reusable Surgical Cutting ToolsGFA · Traditional | 07/12/1995SE |
| K950375 | Disposable & Reusable Bipolar Suction CoagulatorGEI · Traditional | 06/14/1995SE |
| K951912 | Disoposable & Resuable Monpolar CordGEI · Traditional | 05/12/1995SE |
| K951269 | Disposable & Reusable Monopolar Handswithc PencilGEI · Traditional | 04/24/1995SE |
| K950877 | Reusable Monopolar ForcepsGEI · Traditional | 03/09/1995SE |
| K945893 | Disposable & Reusable Monopolar Electrosurigical ElectrodeGEI · Traditional | 12/13/1994SE |
| K945717 | Electrosurgical Endoscopic CordGEI · Traditional | 12/08/1994SE |
Questions and answers
When was Disposable & Resuable Irrigation/Aspiration Handpiece cleared by the FDA?
Disposable & Resuable Irrigation/Aspiration Handpiece (K945171) received a 510(k) decision of Substantially Equivalent on February 8, 1995, 110 days after the submission was received.
What is the product code of K945171?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.