TEMED Gas Diffuser
by Temed
510(k) K173545
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173545 | Date14 Feb 2018 | 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- Withdrawn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
- HIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The TEMED Gas Diffuser is a single patient use disposable surgical device for the effective insufflation of carbon dioxide (CO₂) into an open surgical wound. It is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism.
The device has a microporous, hydrophobic, atraumatic tip that allows precise placement into the surgical field and ensures carbon dioxide is diffused over the majority of its surface, creating a 100% CO₂ atmosphere. It is supplied as a single-use device and is regulated under FDA 510K clearance with product code HIF.
Other devices from Temed
Questions
AI-generated answers, 28 Sep 2026
What is the TEMED Gas Diffuser used for?
The TEMED Gas Diffuser is a single patient use disposable surgical device designed for the effective insufflation of carbon dioxide (CO₂) into an open surgical wound. It is specifically intended for cardiovascular surgeons in open heart surgery procedures to create a 100% CO₂ atmosphere in the thoracic cavity, reducing the risk of air embolism.
How is the TEMED Gas Diffuser supplied and is it reusable?
The TEMED Gas Diffuser is supplied as a single-use device and should not be reused. It features a microporous, hydrophobic, atraumatic tip that allows precise placement into the surgical field and ensures carbon dioxide is diffused over the majority of its surface.
What regulatory approvals does the TEMED Gas Diffuser have?
The TEMED Gas Diffuser is regulated under FDA 510K clearance with product code HIF. It received traditional clearance with a decision code of SESE (Substantially Equivalent) on February 14, 2018, after being received on November 16, 2017.
What makes the TEMED Gas Diffuser design effective for insufflation?
The device has a microporous, hydrophobic, atraumatic tip that allows precise placement into the surgical field. This design ensures carbon dioxide is diffused over the majority of its surface, creating a 100% CO₂ atmosphere which is critical for reducing air embolism risk during open heart surgery procedures.