Hysteromat Hysteroflator Hysteroscopic Insufflator
by Frigitronics, Inc. 510(k)
Active
510(k) K905495
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905495 | Date29 Apr 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HIG
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1700
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope. This device is classified as a Class II medical device under FDA product code HIG and regulation 21 CFR 884.1700.
It received FDA 510(k) clearance through the traditional pathway on April 29, 1991, under K905495, and is manufactured by Frigitronics, Inc. The device is intended for use in obstetrics and gynecology settings as part of hysteroscopic procedures.
Other devices from Frigitronics, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the HYSTEROMAT HYSTEROFLATOR used for?
The HYSTEROMAT HYSTEROFLATOR is a hysteroscopic insufflator designed to distend the uterus by filling the uterine cavity with liquid or gas, which facilitates viewing with a hysteroscope during diagnostic or operative hysteroscopic procedures in obstetrics and gynecology settings.
How is the HYSTEROMAT HYSTEROFLATOR supplied and is it reusable?
The device is supplied as a reusable hysteroscopic insufflator system intended for multiple uses after proper cleaning, disinfection, and sterilization in accordance with the manufacturer's instructions, as it is not labeled as single-use and is designed for repeated clinical use in OB/GYN procedures.
What regulatory pathway was used for the HYSTEROMAT HYSTEROFLATOR and when was it cleared?
The HYSTEROMAT HYSTEROFLATOR received FDA 510(k) clearance through the traditional pathway on April 29, 1991, under submission number K905495, demonstrating substantial equivalence to a legally marketed predicate device for hysteroscopic insufflation.