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Focused Cryotherapy System Console FC-AR401

by Focused Cryo, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860010618035 UDI-DIDate8 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Focused Cryotherapy System Console
Generic Name
General cryosurgical system, cryogen gas, electronic
Model / Ref / Catalog
FC-AR401, SPC-CRYO-3347
Primary DI / UDI-DI
00860010618035
510(k) Number
FDA Product Code
GEH
GMDN Term
General cryosurgical system, cryogen gas, electronic
Device Class
Class II
Regulation Number
878.4350
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K250742)

Other devices from Focused Cryo, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No