MQU · Ocular Peg
Ophthalmic · 21 CFR 886.3320 · Class 2
Overview
| Product Code | MQU |
|---|---|
| Device Name | Ocular Peg |
| Regulation | 21 CFR 886.3320 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Classification Rationale
Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | Apr 10, 2000 | SESE |
| K980822 | TITANIUM PEG SYSTEM | Fci Ophthalmics, Inc. | Jul 9, 1998 | SESE |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | Feb 4, 1998 | SESE |
| K971583 | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Porex Technologies Corp. | Jun 30, 1997 | SESE |
Top Applicants
- Integrated Orbital Implants, Inc. — 2 clearances
- Fci Ophthalmics, Inc. — 1 clearance
- Porex Technologies Corp. — 1 clearance
