# K160591: D.O.R.C. Disposable Cryo Probe

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic Research Center International BV
- Decided: Jan 23, 2017 after 328 days
- Product code: HRN (Unit, Cryophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874555 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012821: D.O.R.C. Cryostar Cryosurgical System, Dutch Ophthalmic USA, Inc. (2001) Summary page 4.
- K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes, Keeler, Ltd. (2013) Summary page 4.

## Indications for use
The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior or anterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.

Source page: https://510kreport.com/device/K160591
Methodology: https://510kreport.com/methodology