Cryomedics 5000 Cryoprobes

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

510(k) Number

K832140 ↗

FDA Product Code

GEH

FDA applicant

Spembly Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Selector Ultrasonic Surgical Aspirator

  Unclassified

  FDA 510(k) K901974 Active Cleared 5 Sep 1990

• Spembly 9000 & 9300

  Class II

  FDA 510(k) K802063 Active Cleared 3 Oct 1980

• Cryoprobes Mc-1400-Cryosurg-Console

  Class II

  FDA 510(k) K832385 Active Cleared 12 Sep 1983

• Obstetric Pulsar Two Channel Tens

  Class II

  FDA 510(k) K840497 Active Cleared 16 Apr 1984

• Cryomedics Neurostat

  Class II

  FDA 510(k) K831963 Active Cleared 12 Aug 1983

• Various Cardiac Cryoprobes Having Dia. & Cos. Diff

  Class II

  FDA 510(k) K874367 Active Cleared 4 Jan 1988

See all devices from Spembly Medical, Ltd. →

• What are the Cryomedics 5000 Cryoprobes used for?

  The Cryomedics 5000 Cryoprobes are cryosurgical accessories designed for use in medical procedures, specifically for tissue destruction during surgical interventions in general and plastic surgery.

• How are the Cryomedics 5000 Cryoprobes supplied?

  The device is supplied by Spembly Medical, Ltd. as part of a cryosurgical unit system that utilizes extreme cold for tissue destruction during surgical procedures.

• What is the regulatory status of the Cryomedics 5000 Cryoprobes?

  The device is classified as a Class II medical device with product code GEH and received FDA 510(k) clearance on August 12, 1983, with the K number K832140.

• What is the intended use of the Cryomedics 5000 Cryoprobes?

  The Cryomedics 5000 Cryoprobes are intended for use in general and plastic surgery procedures as cryosurgical accessories that utilize extreme cold for tissue destruction.