Lewicky O.R.S. Tubing
FDA 510(k) K922180 · O.R. Specialties, Inc.
510(k) numberK922180
Submission
- Device name
- Lewicky O.R.S. Tubing
- Applicant
- O.R. Specialties, Inc.
Tuscaloosa, AL, US - Received
- May 8, 1992
- Decision date
- July 2, 1992
- 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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|---|---|---|---|
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| 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 |
|---|---|---|
| K942607 | Laparoscopic Scissors (Disposable)GEI · Traditional | 07/06/1994SE |
| K923630 | Phaco Needles 1000-R & 1000-O NeedlesHQC · Traditional | 04/06/1994SE |
| K925671 | Disposable Scleral PlugsLXP · Traditional | 08/02/1993SE |
| K923887 | Jack's Vent TubesETD · Traditional | 02/19/1993SE |
| K923774 | Disposable EndoilluminatorEQH · Traditional | 10/19/1992SE |
| K922355 | Polly's Vitreous Scissors J-225-SHQE · Traditional | 08/18/1992SE |
| K914038 | Polly's Cutter J-225HQE · Traditional | 12/09/1991SE |
| K911932 | J105 James Surgical System I/A PackGZX · Traditional | 08/26/1991SE |
| K890195 | James Surgical System J1000HQE · Traditional | 08/03/1989SE |
| K891161 | Vitrectomy Pack #J120HQC · Traditional | 05/26/1989SE |
Questions and answers
When was Lewicky O.R.S. Tubing cleared by the FDA?
Lewicky O.R.S. Tubing (K922180) received a 510(k) decision of Substantially Equivalent on July 2, 1992, 55 days after the submission was received.
What is the product code of K922180?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.