Argyle Universal Poole Suction Tube
510(k) K803187
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK803187 | Date9 Jan 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Argyle Universal Poole Suction Tube is a suction catheter and tip device. It is designed to facilitate the removal of fluids and debris from a surgical site or body cavity.
This device is classified under regulation 880.6740 and is intended for use in a general hospital setting. It has received FDA 510(k) clearance under the submission number K803187.
Other devices from Sherwood Medical Co.
Questions
AI-generated answers, 26 Sep 2026
What is the primary function of the Argyle Universal Poole Suction Tube?
This device is a suction catheter and tip designed to facilitate the removal of fluids and debris from a surgical site or body cavity during medical procedures.
In what clinical environment is this suction tube intended to be used?
The device is intended for use in a general hospital setting, as indicated by its classification under regulation 880.6740.
What is the regulatory status of this suction device?
The Argyle Universal Poole Suction Tube has received FDA 510(k) clearance under submission number K803187, having been determined to be substantially equivalent to existing devices.