Titanium Peg System
FDA 510(k) K980822 · Fci Ophthalmics, Inc.
510(k) numberK980822
Submission
- Device name
- Titanium Peg System
- Applicant
- Fci Ophthalmics, Inc.
Marshfield Hills, MA, US - Received
- March 3, 1998
- Decision date
- July 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MQU – Ocular Peg
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code MQU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000151 | Perry-Kolberg (PK) Ha-Coated Titanium SleeveMQU · Traditional | Integrated Orbital Implants, Inc. | 04/10/2000SE |
| K974203 | Perry-Kolberg (PK) Titanium Motility/Support SystemMQU · Traditional | Integrated Orbital Implants, Inc. | 02/04/1998SE |
| K971583 | Medpor Ocular Screw and AcceossoriesMQU · Traditional | Porex Technologies Corp. | 06/30/1997SE |
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| K041869 | Self Retaining Bicanaliculus Intubation SetOKS · Traditional | 11/18/2004SE |
| K023758 | Becker Transnasal Lacrimal (Intubation Sets)OKS · Traditional | 09/17/2003SE |
| K023400 | Fci Mesh Wrapped Bioceramic Orbital ImplantHPZ · Traditional | 08/22/2003SE |
| K030054 | Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional | 02/26/2003SE |
| K992294 | Bioceramic Orbital ImplantHPZ · Traditional | 04/19/2000SE |
| K991238 | Fci Crawford Probe Intubation SetsOKS · Traditional | 07/08/1999SE |
| K980816 | Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional | 09/18/1998SE |
| K964774 | Punctum Plugs & Ready-Set Punctal PlugsLZU · Traditional | 12/20/1996SE |
Questions and answers
When was Titanium Peg System cleared by the FDA?
Titanium Peg System (K980822) received a 510(k) decision of Substantially Equivalent on July 9, 1998, 128 days after the submission was received.
What is the product code of K980822?
The FDA product code is MQU – Ocular Peg, a Class II (moderate risk) device regulated under 21 CFR 886.3320.