Bladeworks Disposable Alk Tubing
FDA 510(k) K993591 · Blade Works, Inc.
510(k) numberK993591
Submission
- Device name
- Bladeworks Disposable Alk Tubing
- Applicant
- Blade Works, Inc.
Laguna Niguel, CA, US - Received
- October 22, 1999
- Decision date
- December 28, 1999
- 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
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 |
| 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 |
| K940392 | Peregrine Pic MinipulatorKYG · Traditional | Peregrine Surgical , Ltd. | 08/23/1994SE |
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Questions and answers
When was Bladeworks Disposable Alk Tubing cleared by the FDA?
Bladeworks Disposable Alk Tubing (K993591) received a 510(k) decision of Substantially Equivalent on December 28, 1999, 67 days after the submission was received.
What is the product code of K993591?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.