Molteno Valve Seton
FDA 510(k) K875099 · Staar Surgical Co.
510(k) numberK875099
Submission
- Device name
- Molteno Valve Seton
- Applicant
- Staar Surgical Co.
Monrovia, CA, US - Received
- December 10, 1987
- Decision date
- March 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYF – Implant, Eye Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3920
- Specialty
- Ophthalmic
- Implant
- Yes
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| K152996 | Molteno3 Glaucoma ImplantKYF · Traditional | Innovative Ophthalmic Products, Inc. (Iop) | 12/17/2015SE |
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More from New World Medical, 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 Molteno Valve Seton cleared by the FDA?
Molteno Valve Seton (K875099) received a 510(k) decision of Substantially Equivalent on March 30, 1988, 111 days after the submission was received.
What is the product code of K875099?
The FDA product code is KYF – Implant, Eye Valve, a Class II (moderate risk) device regulated under 21 CFR 886.3920.