InsufflatOR Needle
by Gynetech Pty., Ltd. 510(k)
Active
510(k) K142700
Overview
The InsufflatOR Needle is a Class 2 medical device in the Obstetrics/Gynecology specialty, identified by product code HIF and regulation number 884.1730 (21 CFR 884.1730). It is a laparoscopic insufflator needle designed for use in minimally invasive surgical procedures to establish pneumoperitoneum.
The device received FDA 510(k) clearance (K142700) through the Traditional pathway on December 19, 2014, following an 88-day review. It is manufactured by Gynetech Pty. Ltd. and is available in sizes including 12cm and 15cm as indicated in the labeling.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142700 | Date19 Dec 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HIF
- FDA applicant
- Gynetech Pty. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Gynetech Pty., Ltd.
Questions
What is the InsufflatOR Needle used for?
The InsufflatOR Needle is a laparoscopic insufflator needle designed to establish pneumoperitoneum during minimally invasive surgical procedures, allowing surgeons to create working space in the abdominal cavity for laparoscopy.
How is the InsufflatOR Needle supplied and what sizes are available?
The InsufflatOR Needle is supplied as a sterile, single-use device and is available in two sizes: 12cm and 15cm, as indicated in the product labeling for laparoscopic insufflation.
Is the InsufflatOR Needle reusable or single-use?
The InsufflatOR Needle is intended for single-use only; it is supplied sterile and should be discarded after one procedure to prevent cross-contamination and ensure optimal performance.