510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230011Unknown

OcuCool

Recensmedical Inc., Hwaseong-Si, KR / Direct, Unknown
FDA source (opens on fda.gov)

DEN230011 is the FDA 510(k) clearance record for OcuCool, cleared for Recensmedical, Inc. on under FDA product code QZQ. FDA records list 7 510(k) clearances for Recensmedical, Inc., from to . As of , FDA records show no recalls naming DEN230011.

Clearance record

Decision date
Received
(592 days to decision)
Product code
QZQ
Review panel
Unknown
Applicant
Recensmedical, Inc. #507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero, Hwaseong-Si, KR
Third party review
No

Clearances, product code QZQ

Trailing 12 months

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

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