Guedel Airways
by Precision Med Products, Ltd.
510(k) K932711
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932711 | Date23 Jul 1993 | 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- Withdrawn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
- Full name
- Precision Med Products Ltd Guedel Airways
- 510(k) Number
- FDA Product Code
- BTR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5730
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Guedel Airways is a tracheal tube, classified as a class 2 medical device. It is used in anesthesiology.
The device is supplied by Precision Med Products, Ltd. and has been granted FDA 510(k) clearance, with the decision being substantially equivalent. The device has a regulation number of 868.5730 and a product code of BTR.
Other devices from Precision Med Products, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Guedel Airways used for?
The Guedel Airways is used in anesthesiology as a tracheal tube.
What is the regulatory classification of the Guedel Airways?
The Guedel Airways is classified as a class 2 medical device with a regulation number of 868.5730.
Has the Guedel Airways received FDA clearance?
Yes, the Guedel Airways has been granted FDA 510(k) clearance, with the decision being substantially equivalent.