Baervelt Pars Plana Glaucoma Implant
FDA 510(k) K955455 · Pharmacia Iovision, Inc.
510(k) numberK955455
Submission
- Device name
- Baervelt Pars Plana Glaucoma Implant
- Applicant
- Pharmacia Iovision, Inc.
Peapack, NJ, US - Received
- November 29, 1995
- Decision date
- February 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYF – Implant, Eye Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3920
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code KYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231051 | Ahmed® Glaucoma Valve Model FP8KYF · Special | New World Medical, Inc. | 05/12/2023SE |
| K230975 | Ahmed® Glaucoma Valve Model FP7KYF · Special | New World Medical, Inc. | 05/12/2023SE |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3KYF · Traditional | Glaukos Corporation | 08/02/2022SE |
| K182518 | AHMED ClearPath Glaucoma Drainage DeviceKYF · Traditional | New World Medical, Inc. | 01/18/2019SE |
| K171451 | Ahmed Glaucoma Valve Model FP8KYF · Traditional | New World Medical, Inc. | 08/08/2017SE |
| K161457 | XEN Glaucoma Treatment SystemKYF · Traditional | Allergan, Inc. | 11/21/2016SE |
| K162060 | Ahmed Glaucoma ValveKYF · Traditional | New World Medical, Inc. | 10/24/2016SE |
| K152996 | Molteno3 Glaucoma ImplantKYF · Traditional | Innovative Ophthalmic Products, Inc. (Iop) | 12/17/2015SE |
| K062252 | MOLTENO3KYF · Traditional | Iop, Inc. | 09/27/2006SE |
| K060644 | Ahmed Glaucoma Valve, Model M4KYF · Traditional | New World Medical, Inc. | 09/18/2006SE |
Questions and answers
When was Baervelt Pars Plana Glaucoma Implant cleared by the FDA?
Baervelt Pars Plana Glaucoma Implant (K955455) received a 510(k) decision of Substantially Equivalent on February 18, 1997, 447 days after the submission was received.
What is the product code of K955455?
The FDA product code is KYF – Implant, Eye Valve, a Class II (moderate risk) device regulated under 21 CFR 886.3920.