Insite Filter & Tubing Set
by Andronic Devices, Ltd. 510(k)
Active
510(k) K934928
Overview
The Insite Filter & Tubing Set is a medical device used in the field of Obstetrics/Gynecology. It is classified as a device with a product code of HIF and is regulated under the regulation number 884.1730.
The device is supplied by Andronic Devices, Ltd. and has received FDA 510(k) clearance, indicated by the clearance number K934928. The device is used in medical settings, but specific details on its usage, sterility, and storage are not provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934928 | Date26 May 1994 | 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- Withdrawn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
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Andronic Devices, Ltd.
Questions
What is the Insite Filter & Tubing Set used for?
The Insite Filter & Tubing Set is used in the field of Obstetrics/Gynecology, but specific details on its usage are not provided.
Is the Insite Filter & Tubing Set sterile?
The available data does not provide information on the sterility of the Insite Filter & Tubing Set.
What is the regulatory status of the Insite Filter & Tubing Set?
The Insite Filter & Tubing Set has received FDA 510(k) clearance, indicated by the clearance number K934928.