510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972034Substantially Equivalent

Medpor Ocular Conformer

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

K972034 is the FDA 510(k) clearance record for MEDPOR OCULAR CONFORMER, a class II device, cleared for Porex Surgical, Inc. on under FDA product code HQN (Conformer, Ophthalmic). FDA records list 19 510(k) clearances for Porex Surgical, Inc., from to . As of , FDA records show one recall naming K972034.

Clearance record

Decision date
Received
(232 days to decision)
Product code
HQN Conformer, Ophthalmic
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Applicant
Porex Surgical, Inc. 500 Bohannon Rd., Fairburn GA
510(k) summary
Summary
Third party review
No

Clearances, product code HQN

Trailing 12 months

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

FDA records show no clearances under product code HQN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQN, 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