CCS100 Cryosurgical System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K811390 ↗

FDA Product Code

GEH

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Keates Irrigation/Aspiration/Vitreous

  Class II

  FDA 510(k) K834437 Active Cleared 30 Mar 1984

• Frigitronics Acc-1000 Capsule Cutter

  Class II

  FDA 510(k) K872362 Active Cleared 27 Jul 1987

• CS-76 And/Or Cryocare I

  Class II

  FDA 510(k) K760742 Active Cleared 3 Nov 1976

• I/A Probe Lines

  Not classified

  FDA 510(k) K834577 Active Cleared 22 May 1984

• Keates Irrigation/Aspiration/Vitreous Cutter 5000

  Class II

  FDA 510(k) K853308 Active Cleared 4 Oct 1985

• Keates I/a System Frigitronics 4000

  Class II

  FDA 510(k) K822599 Active Cleared 6 Oct 1982

See all devices from Frigitronics of Connecticut, Inc. →

• What is the primary function of the CCS100 Cryosurgical System?

  The CCS100 is a cryosurgical unit and accessory device designed to perform cryosurgical procedures by utilizing controlled cold temperatures.

• What is the regulatory classification of this device?

  The CCS100 is classified as a Class 2 medical device under 21 CFR 878.4350 and has received FDA 510(k) clearance.

• Which medical specialty is this device associated with?

  The device is categorized under the General and Plastic Surgery advisory committee, as indicated by the regulatory filing data.