Bacstop Filter Irrigation Supply Kit
FDA 510(k) K860544 · Staar Surgical Co.
510(k) numberK860544
Submission
- Device name
- Bacstop Filter Irrigation Supply Kit
- Applicant
- Staar Surgical Co.
Monrovia, CA, US - Received
- February 13, 1986
- Decision date
- April 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
Other 510(k)s with product code KYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010353 | Med-Logics Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 04/27/2001SE |
| 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 |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
More from Boston Surgical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172375 | MicroSTAAR Injector System CartridgesMSS · Special | 09/06/2017SE |
| K152357 | MicroSTAAR Injector System CartridgesKYB · Special | 10/30/2015SE |
| K090161 | Epiphany Injection SystemMSS · Traditional | 06/09/2009SE |
| K073591 | Microstaar Msi Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K073586 | Microstaar Indigo Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | 06/10/2004SE |
| K020734 | Surge-Free Aspiration AdapterHQC · Traditional | 05/16/2002SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | 12/04/1998SE |
| K980696 | Foam Tip InjectorMSS · Traditional | 09/11/1998SE |
| K954600 | Microstaar Injector Models Msi-Td & Msi-Pd (Modification)KYB · Traditional | 12/21/1995SE |
Questions and answers
When was Bacstop Filter Irrigation Supply Kit cleared by the FDA?
Bacstop Filter Irrigation Supply Kit (K860544) received a 510(k) decision of Substantially Equivalent on April 4, 1986, 50 days after the submission was received.
What is the product code of K860544?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.