Maxi-Flow Suction Set W/Y Connector
by Adler Instrument Co. 510(k)
Active
510(k) K910171
Overview
The Maxi-Flow Suction Set W/Y Connector is a medical device designed for suction purposes in clinical settings. It is classified under product code GAZ and is intended for use in general hospital environments.
This device is supplied by Adler Instrument Co. and received FDA 510(k) clearance with number K910171 on February 1, 1991, determined to be substantially equivalent. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910171 | Date1 Feb 1991 | 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- Withdrawn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
- GAZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Adler Instrument Company
Questions
What is the Maxi-Flow Suction Set W/Y Connector used for?
The Maxi-Flow Suction Set W/Y Connector is designed for suction purposes in clinical settings, specifically intended for use in general hospital environments to assist with medical procedures requiring fluid or air removal.
Is the Maxi-Flow Suction Set single-use or reusable?
The device data does not specify whether the Maxi-Flow Suction Set is designed for single-use or reusable purposes. This information should be obtained directly from the manufacturer or product documentation.
What regulatory approvals does the Maxi-Flow Suction Set have?
The Maxi-Flow Suction Set W/Y Connector received FDA 510(k) clearance with number K910171 on February 1, 1991, and was determined to be substantially equivalent to predicate devices under product code GAZ.
What are the specifications of the Maxi-Flow Suction Set?
The device is classified under product code GAZ and is intended for general hospital use. Specific measurements, materials, or detailed technical specifications are not provided in the available data.