Endolap Insufflator Tubing Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K950219 ↗

FDA Product Code

HIF

Device Class

Class II

Regulation

21 CFR Part 884.1730

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Endolap Resectoscope Cutting Loop Electrode

  Class II

  FDA 510(k) K974516 Active Cleared 22 Dec 1997

• Titan Insufflation Needle

  Class II

  FDA 510(k) K950243 Active Cleared 6 Apr 1995

• Esys System

  Class II

  FDA 510(k) K933492 Active Cleared 25 Mar 1994

• Endolap Resectoscope Roller Electrode

  Class II

  FDA 510(k) K974515 Active Cleared 22 Dec 1997

• What is the Endolap Insufflator Tubing Set used for?

  The Endolap Insufflator Tubing Set is used to deliver insufflation gas, typically carbon dioxide, from an insufflation pump to a laparoscopic port or needle to create and maintain a pneumoperitoneum during laparoscopic procedures, specifically in obstetrics and gynecology applications.

• Is the Endolap Insufflator Tubing Set sterile or non-sterile, and is it reusable?

  The device is supplied as a non-sterile accessory and is designated for single-use only; it is not intended for cleaning, sterilization, or reuse due to the risk of contamination and potential compromise of material integrity after one use.

• How is the Endolap Insufflator Tubing Set supplied and what are its regulatory details?

  The device is supplied as a tubing set component for laparoscopic insufflation systems and received FDA 510(k) clearance under K950219 as substantially equivalent to a legally marketed device; it is classified as a Class II medical device under regulation 884.1730 with product code HIF.