Pneumoperitoneum Insufflation Needle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K021247 ↗

FDA Product Code

HIF

Device Class

Class II

Regulation

21 CFR Part 884.1730

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Tubalgator

  Class II

  FDA 510(k) K113080 Active Cleared 29 Jun 2012

• 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

See all devices from Mectra Labs, Inc. →