Intraducer

• • Terminated Z-0277-2016 FDA Class II ·initiated 14 Oct 2015

  The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.

510(k) Number

K992907 ↗

FDA Product Code

GBW

Device Class

Class I

Regulation

21 CFR Part 878.4200

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• O.P.C. Intravascular Catheter

  Class II

  FDA 510(k) K875082 Active Cleared 8 Mar 1988

• Taut Balloon Catheter, Model 50640

  Class II

  FDA 510(k) K011018 Active Cleared 22 Jun 2001

• Tuat Splatter Control Shield Scs-300

  Class II

  FDA 510(k) K962003 Active Cleared 18 Jul 1996

• Adapt Open Access Port, Model 41233

  Class II

  FDA 510(k) K021731 Active Cleared 8 Aug 2002

• Taut-Insufflation Needle

  Class II

  FDA 510(k) K003703 Active Cleared 22 Feb 2001

• Mini-Port

  Class I

  FDA 510(k) K992904 Active Cleared 5 Oct 1999

See all devices from Taut, Inc. →