Tubalgator

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K113080 ↗

FDA Product Code

HIN

Device Class

Class II

Regulation

21 CFR Part 884.4150

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Insufflation Tubing

  Class II

  FDA 510(k) K925691 Active Cleared 23 Sep 1993

• Graspers

  Class II

  FDA 510(k) K935382 Active Cleared 15 Feb 1994

• Insufflator, Laparoscopic

  Class II

  FDA 510(k) K920959 Active Cleared 13 Jul 1992

• Electro-Lube

  Class II

  FDA 510(k) K033880 Active Cleared 10 Mar 2004

• Mectra Trocar

  Class II

  FDA 510(k) K934547 Active Cleared 18 Feb 1994

• Pneumoperitoneum Insufflation Needle

  Class II

  FDA 510(k) K021247 Active Cleared 8 Nov 2002

See all devices from Mectra Labs, Inc. →