510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160591Substantially Equivalent

D.O.R.C. Disposable Cryo Probe

Dutch Ophthalmic Research Center International BV, Zuidland, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160591 is the FDA 510(k) clearance record for D.O.R.C. Disposable Cryo Probe, a class II device, cleared for Dutch Ophthalmic Research Center International BV on under FDA product code HRN (Unit, Cryophthalmic, Ac-Powered). FDA records list 4 510(k) clearances for Dutch Ophthalmic Research Center International BV, from to . As of , FDA records show no recalls naming K160591.

Clearance record

Decision date
Received
(328 days to decision)
Product code
HRN Unit, Cryophthalmic, Ac-Powered
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Dutch Ophthalmic Research Center International BV Scheijdelveweg 2, Zuidland, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRN

Trailing 12 months

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

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