HysteroFlator 2001
by Cabot Medical Corp. 510(k)
Active
510(k) K895907
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895907 | Date14 Dec 1989 | 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- Withdrawn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, 1 Oct 2026
The HysteroFlator 2001 is an Insufflator, Hysteroscopic, a medical device used in Obstetrics/Gynecology. It is designed to provide insufflation for hysteroscopic procedures. The device is classified as a class 2 device.
The HysteroFlator 2001 is supplied by Cabot Medical Corp. and has been granted FDA 510K clearance. The device has a product code of HIG and is regulated under regulation number 884.1700. It is available in a single model, K895907, and is intended for use in medical settings, specifically in obstetrics and gynecology.
Other devices from Cabot Medical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the HysteroFlator 2001 used for?
The HysteroFlator 2001 is used to provide insufflation for hysteroscopic procedures in medical settings, specifically in obstetrics and gynecology.
Is the HysteroFlator 2001 a single-use device?
The device data does not specify if the HysteroFlator 2001 is for single-use or reuse, it is recommended to consult the manufacturer's instructions for use.
What is the regulatory classification of the HysteroFlator 2001?
The HysteroFlator 2001 is classified as a class 2 device, regulated under regulation number 884.1700, and has been granted FDA 510K clearance.