Rigid Suction Tips
by Kelleher Corp. 510(k)
Active
510(k) K822255
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822255 | Date25 Aug 1982 | 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- Withdrawn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
- KTR
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4680
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Rigid Suction Tips are classified as a rigid bronchoscope aspirating tube. This device is designed to facilitate suctioning procedures within the ear, nose, and throat medical specialty.
This device is a Class II medical device regulated under 21 CFR 874.4680. It has received FDA 510(k) clearance under the identifier K822255.
Other devices from Kelleher Corp.
Questions
AI-generated answers, 26 Sep 2026
What is the primary clinical use for the Rigid Suction Tips?
These devices are designed to function as rigid bronchoscope aspirating tubes. They are specifically intended to facilitate suctioning procedures during medical interventions within the ear, nose, and throat specialty.
How is this device regulated?
The Rigid Suction Tips are classified as a Class II medical device under 21 CFR 874.4680. The device has received FDA 510(k) clearance under the identifier K822255, confirming it is substantially equivalent to predicate devices.
Who is the manufacturer of these suction tips?
The Rigid Suction Tips are manufactured by Kelleher Corp., located in McHenry, Illinois. The company manages the production and regulatory filings for this specific aspirating tube.