Adapt Open Access Port, Model 41233

• • Terminated Z-1327-2014 FDA Class II ·initiated 11 Mar 2014

  Complaints of leakage of insufflation gas through the device.

• • Terminated Z-1285-2014 FDA Class II ·initiated 11 Mar 2014

  Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

510(k) Number

K021731 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

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

• 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

• Operative Cholangiogram Catheter

  Class I

  FDA 510(k) K924981 Active Cleared 6 Apr 1993

See all devices from Taut, Inc. →