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Focused Cryotherapy System Directional Cryoprobe FC-2021CD01

by Focused Cryo, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860010618066 UDI-DI Date8 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Focused Cryotherapy System Directional Cryoprobe
Generic Name
General cryosurgical system, cryogen gas, electronic
Model / Ref / Catalog
FC-2021CD01, SPC-CRYO-1112
Primary DI / UDI-DI
00860010618066
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
Size
Needle Gauge — 14 Gauge

Related devices

Cleared under the same submission (K250742)

Other devices from Focused Cryo, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No