Biopsy Forceps
by Annex Medical, Inc. 2 variants
510(k) K921401
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921401 | Date21 Oct 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DWZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4075
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Biopsy Forceps is a Biopsy, Endomyocardial device, classified under the FDA’s Device Class II, designed for the retrieval of tissue samples from cardiac tissue. It is engineered for precision in cardiac procedures, enabling clinicians to obtain endomyocardial biopsies—critical for diagnosing and monitoring heart conditions such as cardiomyopathies, myocarditis, or rejection in transplant patients. Constructed with materials suitable for cardiac intervention, it is intended for use in catheter-based procedures where tissue sampling is required for histopathological analysis.
This device is supplied sterile and intended for single-use, adhering to FDA’s 510(k) clearance under the Traditional review pathway with a Substantially Equivalent determination. It is manufactured by Annex Medical, Inc., and distributed under the product code DWZ, regulated under 21 CFR 870.4075. The forceps are designed for use in controlled clinical settings, such as cardiac catheterization labs, and must be stored in accordance with manufacturer instructions to maintain sterility and functionality. No MRI safety information is specified in the regulatory data.
Other devices from Annex Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Biopsy Forceps designed for?
The Biopsy Forceps is specifically engineered for retrieving tissue samples from cardiac tissue during endomyocardial biopsy procedures. This is critical for diagnosing and monitoring heart conditions such as cardiomyopathies, myocarditis, or rejection in transplant patients. The precision design ensures accurate sampling in controlled catheter-based interventions.
How is the Biopsy Forceps supplied and intended for use?
The Biopsy Forceps is supplied sterile and is intended for single-use only. This ensures patient safety and maintains sterility during cardiac procedures. It is designed exclusively for use in clinical settings like cardiac catheterization labs, where tissue sampling is required for histopathological analysis.
What regulatory pathway does the Biopsy Forceps follow?
The Biopsy Forceps has received FDA clearance under the Traditional review pathway with a Substantially Equivalent determination. This classification under Device Class II reflects its role in cardiac interventions, where precision and reliability are essential. The device is regulated under 21 CFR 870.4075.
What storage instructions should be followed to maintain sterility?
To preserve sterility and functionality, the Biopsy Forceps must be stored strictly according to the manufacturer’s instructions. Improper storage could compromise its integrity, so adherence to these guidelines is critical for clinical use. The device is not intended for reuse, further emphasizing the need for proper handling.
Are there any specific safety considerations for this device?
The Biopsy Forceps is designed for use in controlled clinical environments, such as cardiac catheterization labs. While no MRI safety information is specified in the regulatory data, clinicians should always verify compatibility with their facility’s imaging protocols before use. The device’s single-use nature also reduces cross-contamination risks.