FDA product code MQU: Ocular Peg
MQU is the FDA product code for ocular peg. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under MQU, from 3 different applicants. The average 510(k) review took 89 days (median 84). FDA has posted 1 recall for MQU devices.
Classification
| Field | Value |
|---|---|
| Device name | Ocular Peg |
| Device class | Class II |
| Regulation | 21 CFR 886.3320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MQU clearance
Top MQU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Integrated Orbital Implants, Inc. | 2 | 2000-04-10 |
| Fci Ophthalmics, Inc. | 1 | 1998-07-09 |
| Porex Technologies Corp. | 1 | 1997-06-30 |
Most recent MQU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000151 | Integrated Orbital Implants, Inc. | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | 2000-04-10 | 82 |
| K980822 | Fci Ophthalmics, Inc. | TITANIUM PEG SYSTEM | 1998-07-09 | 128 |
| K974203 | Integrated Orbital Implants, Inc. | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | 1998-02-04 | 86 |
| K971583 | Porex Technologies Corp. | MEDPOR OCULAR SCREW AND ACCEOSSORIES | 1997-06-30 | 61 |
Recalls for MQU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-12-20.
Frequently asked questions
What is FDA product code MQU?
MQU is the FDA product code for ocular peg. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel.
What device class is MQU?
Class II, regulation 21 CFR 886.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code MQU?
Across 4 cleared submissions the average was 89 days from receipt to decision (median 84).
Which companies have the most MQU clearances?
Integrated Orbital Implants, Inc. (2); Fci Ophthalmics, Inc. (1); Porex Technologies Corp. (1).
Have MQU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MQU
- Run a recall and safety report across every MQU manufacturer
- Watch product code MQU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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