Biopsy Fixation Unit-Type UA 0997
510(k) K875357
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK875357 | Date1 Jul 1988 | 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- Withdrawn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
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Biopsy Fixation Unit-Type UA 0997 is a Class II medical device classified under the nomenclature code IYO as a System, Imaging, Pulsed Echo, Ultrasonic, designed for radiology applications. This unit is intended for the fixation and stabilization of biopsy specimens, ensuring proper handling and imaging during diagnostic procedures.
This device is supplied as a reusable unit and is regulated under the FDA 510(k) clearance with the designation K875357, granted in 1988. It falls under the Radiology advisory committee and is intended for use in clinical settings where ultrasound imaging is required for biopsy specimen evaluation. No additional sterility or MRI safety information is specified in the regulatory data.
Other devices from Bruel & Kjaer Industri A/S
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Biopsy Fixation Unit-Type UA 0997 in a clinical setting?
The Biopsy Fixation Unit-Type UA 0997 is designed specifically to stabilize and fix biopsy specimens during diagnostic procedures. This ensures proper handling and positioning of the specimen for accurate ultrasound imaging, which is critical for evaluating the sample in radiology applications.
Is this device intended for single-use or can it be reused in a clinical environment?
The Biopsy Fixation Unit-Type UA 0997 is explicitly described as a reusable unit. Since it is not labeled as single-use or sterile, it must be cleaned and maintained according to standard medical device reprocessing protocols to ensure safe and effective use across multiple procedures.
How is this device regulated by the FDA, and what does its classification mean for clinical use?
The Biopsy Fixation Unit-Type UA 0997 is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K875357). This designation means it has been determined to be substantially equivalent to a legally marketed device and is subject to general controls, with special controls specific to its intended use in ultrasound-guided biopsy specimen fixation. It was reviewed by the Radiology Advisory Committee (RA) in 1988.
What types of imaging systems is this device compatible with, and where would it typically be used?
This device is designed for ultrasound imaging systems, specifically within radiology applications where biopsy specimens require stabilization for diagnostic evaluation. It is intended for clinical settings where ultrasound-guided procedures are performed, such as outpatient clinics, hospitals, or diagnostic imaging centers.
Are there any special considerations for storage or handling of the Biopsy Fixation Unit-Type UA 0997?
While the regulatory data does not specify storage conditions, as a reusable medical device, it should be stored in a clean, dry environment to prevent contamination or damage. Since it is not labeled as sterile, it must undergo proper cleaning and maintenance between uses to comply with clinical protocols and ensure reliability for subsequent procedures.