General Purpose Tranducer Cover
by Civco Medical Instruments Co., Inc.
510(k) K970513
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970513 | Date20 Jun 1997 | 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- Withdrawn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
- ITX
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The General Purpose Transducer Cover (K970513) is a sterile barrier device designed to protect ultrasound transducers during diagnostic or interventional procedures. Classified under product code ITX, it serves as a protective sheath to maintain a sterile field while ensuring transducer functionality remains intact. This cover is intended for use with general-purpose ultrasound probes across various clinical specialties, including radiology and point-of-care settings. Its construction adheres to regulatory standards for maintaining sterility and compatibility with ultrasound imaging.
Supplied as a single-use item, the cover is manufactured from latex-free polyethylene to minimize allergenic risks. It is intended for use in sterile procedures, such as punctures or drainage, where contamination risks must be mitigated. The device holds an FDA 510(k) clearance under the Radiology Advisory Committee, with a clearance date of June 20, 1997. Storage and handling should comply with sterile medical device protocols to preserve integrity prior to use.
Other devices from Civco Medical Instruments Co., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the General Purpose Transducer Cover (K970513) used for?
The General Purpose Transducer Cover (K970513) is designed as a sterile barrier to protect ultrasound transducers during diagnostic or interventional procedures. It maintains a sterile field while preserving the transducer’s functionality, making it suitable for use in radiology and point-of-care settings where contamination risks—such as punctures or drainage—must be minimized.
Is the cover latex-free and how does this benefit patients?
Yes, the cover is manufactured from latex-free polyethylene, which reduces the risk of allergic reactions in patients sensitive to latex. This material choice aligns with modern medical device standards to enhance patient safety during procedures.
How is the General Purpose Transducer Cover supplied and intended for use?
The cover is supplied as a single-use item, meaning it is intended for one-time use only to ensure sterility and prevent cross-contamination. After use, it should be discarded, and a new sterile cover applied for subsequent procedures to comply with sterile medical device protocols.
What storage and handling precautions should be taken with this device?
The cover must be stored and handled according to sterile medical device protocols to maintain its integrity before use. This includes keeping it in a sealed, sterile packaging until immediately prior to application and avoiding exposure to moisture, heat, or physical damage that could compromise sterility.
What regulatory clearance does the General Purpose Transducer Cover hold?
The device holds an FDA 510(k) clearance under the Radiology Advisory Committee, classified as substantially equivalent (SESE) to a predicate device. The clearance was granted on June 20, 1997, confirming its compliance with U.S. regulatory standards for ultrasound transducer protection.