Mcghan Tissue Expander Fill Kit

• • Ongoing Z-0134-2024 FDA Class II ·initiated 26 Sep 2023

  Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

510(k) Number

K853014 ↗

FDA Product Code

LCJ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Implant, Eye Sphere

  Class II

  FDA 510(k) K781356 Active Cleared 21 Aug 1978

• Ionotphoretic Applicator

  Class II

  FDA 510(k) K781700 Active Cleared 3 Nov 1978

• Mcghan Tissue Expander

  Unclassified

  FDA 510(k) K843704 Active Cleared 31 Oct 1984

• Otological Ventilation Tubes

  Class II

  FDA 510(k) K780956 Active Cleared 22 Jun 1978

• Mcghan Longterm Mammary Expander/Gel-Saline Design

  Unclassified

  FDA 510(k) K864184 Active Cleared 24 Dec 1986

• Micro-Torque Hand Engine & Access. Dermabra. Burs

  Class I

  FDA 510(k) K873475 Active Cleared 11 Sep 1987

See all devices from Mcghan Medical Corp. →