510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971583Substantially Equivalent

Medpor Ocular Screw and Acceossories

Porex Technologies Corp., Fairburn GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971583 is the FDA 510(k) clearance record for MEDPOR OCULAR SCREW AND ACCEOSSORIES, a class II device, cleared for Porex Technologies Corp. on under FDA product code MQU (Ocular Peg). FDA records list 2 510(k) clearances for Porex Technologies Corp., from to . As of , FDA records show no recalls naming K971583.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MQU Ocular Peg
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Porex Technologies Corp. 500 Bohannon Rd., Fairburn GA
510(k) summary
Summary
Third party review
No

Clearances, product code MQU

Trailing 12 months

FDA records hold no clearances under product code MQU in the trailing twelve months.

FDA records show no clearances under product code MQU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260