Lens Insertion Glide
FDA 510(k) K840694 · Innovative Surgical Products, Inc.
510(k) numberK840694
Submission
- Device name
- Lens Insertion Glide
- Applicant
- Innovative Surgical Products, Inc.
Mchenry, IL, US - Received
- February 16, 1984
- Decision date
- May 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYB – Lens, Guide, Intraocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
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| K081382 | Duckworth & Kent, Ltd., Implantation System, Model DK7786KYB · Traditional | Duckworth & Kent, Ltd. | 10/23/2008SE |
| K072985 | Duckworth & Kent Ltd Injector, Model: DK7797-2KYB · Traditional | Duckworth & Kent, Ltd. | 06/20/2008SE |
| K070669 | Iol Injector SetKYB · Traditional | Medicel AG | 11/01/2007SE |
| K063155 | Monarch III Iol Delivery SystemKYB · Traditional | Alcon Manufacturing, Ltd. | 03/27/2007SE |
| K063694 | Akreos Single Use Insertion Device, Model AI-28KYB · Special | Bausch & Lomb, Inc. | 03/07/2007SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | Staar Surgical Co. | 06/10/2004SE |
| K022723 | Mastel 1 Folder Implantation SystemKYB · Traditional | Mastel Precision, Inc. | 12/26/2002SE |
| K001157 | Monarch II Iol Delivery SystemKYB · Traditional | Alcon Research, Ltd. | 06/27/2000SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | Staar Surgical Co. | 12/04/1998SE |
More from Staar Surgical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K843041 | Heslin Dispos. Tubing SetHQE · Traditional | 11/21/1984SE |
| K840695 | Phacoemulsification KitsHQC · Traditional | 05/22/1984SE |
| K840693 | Disposable Scleral Globe PlugLXP · Traditional | 05/22/1984SE |
| K841072 | Irrigation, Aspiration Tubing SetsHQC · Traditional | 03/29/1984SE |
| K832235 | Disposable Vitrectomy HandpieceHQE · Traditional | 09/29/1983SE |
| K821496 | Disposable Irriga/Aspir. SystemKDH · Traditional | 06/22/1982SE |
| K820765 | Pleural Drainage ReservoirGCX · Traditional | 04/15/1982SE |
| K820680 | Disposable Tubing SetsKYG · Traditional | 04/09/1982SE |
| K802973 | Ispvac TMGCY · Traditional | 12/19/1980SE |
| K801350 | Acuvac(Tm) Suction Reservoir 400CC andGCY · Traditional | 07/14/1980SE |
Questions and answers
When was Lens Insertion Glide cleared by the FDA?
Lens Insertion Glide (K840694) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 83 days after the submission was received.
What is the product code of K840694?
The FDA product code is KYB – Lens, Guide, Intraocular, a Class I (low risk) device regulated under 21 CFR 886.4300.