MQU — Ocular Peg Class II

FDA Device Classification

FDA product code MQU covers "Ocular Peg", a Class II medical device regulated under 21 CFR 886.3320. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MQU
Device Class
Class II
Regulation Number
886.3320
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K000151integrated orbital implantsPERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEApril 10, 2000
K980822fci ophthalmicsTITANIUM PEG SYSTEMJuly 9, 1998
K974203integrated orbital implantsPERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMFebruary 4, 1998
K971583porex technologiesMEDPOR OCULAR SCREW AND ACCEOSSORIESJune 30, 1997