FDA.reportPublic FDA data

FOCUSED CRYO, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
FOCUSED CRYO, INC.5N2027-01-018601 Dunwoody Pl Ste 570 Sandy Springs GA US 30350

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860010618035Focused Cryotherapy System Console - FC-AR4014045944280rkruchten@focusedcryo.com
00860010618066Focused Cryotherapy System Directional Cryoprobe - FC-2021CD014045944280rkruchten@focusedcryo.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3533361583039175K250742Focused Cryotherapy SystemGEH2025-12-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH12025-12-09

GUDID#