Heterodynamic

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

510(k) Number

K821157 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Electrosurgical Pencil Holder 720

  Class II

  FDA 510(k) K850297 Active Cleared 28 Feb 1985

• Hyfrecator, #733

  Class II

  FDA 510(k) K800617 Active Cleared 2 May 1980

• Cardiocassette II #363

  Class II

  FDA 510(k) K821453 Active Cleared 25 May 1982

• Shortwave Diathermy Model 802

  Class II

  FDA 510(k) K780755 Active Cleared 12 May 1978

• Birt-A-Chuck Disposable Electr. Handle

  Class II

  FDA 510(k) K760722 Active Cleared 1 Nov 1976

• Surgical Cauteries Models 775-11, 12, 13, 31, 32 & 33

  Class II

  FDA 510(k) K854814 Active Cleared 13 Jan 1986

See all devices from Birtcher Corp. →