Biopsy Forceps
by Fehling Instruments GmbH & Co. KG Germany 510(k)
510(k) K170726 Product code DWZ
Overview
The Biopsy Forceps is a Cardiovascular Device designed for obtaining endomyocardial biopsy specimens. Classified as a Biopsy, Endomyocardial Device, it is used to retrieve tissue samples from the right and left ventricles via percutaneous arterial or venous access. Its construction enables precise tissue acquisition for diagnostic cardiac evaluation, supporting pathological assessment of myocardial conditions.
These forceps are supplied as single-use instruments, intended for use in sterile cardiac catheterization procedures. They are regulated under FDA 510(k) clearance (K170726) and fall under Device Class II (DWZ product code). Multiple model references are available, ensuring compatibility with various procedural requirements. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170726 | Date2 Jun 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Fehling Instruments GmbH
Questions
What is the primary use of the Fehling Biopsy Forceps?
The Fehling Biopsy Forceps are designed specifically for obtaining endomyocardial biopsy specimens from the right and left ventricles. This allows clinicians to retrieve tissue samples for pathological evaluation of myocardial conditions, aiding in the diagnosis of cardiac diseases. The device is inserted percutaneously through arterial or venous access, ensuring precise tissue acquisition for accurate diagnostic assessment.
Are the Fehling Biopsy Forceps single-use or reusable?
These biopsy forceps are intended for single-use only. They are supplied sterile and must remain unopened until use to maintain sterility. Reuse is not recommended or supported by the manufacturer, as it could compromise patient safety and device integrity. Always follow sterile medical device protocols during storage and handling.
What model references are available for the Fehling Biopsy Forceps?
Multiple model references are available to ensure compatibility with various procedural requirements. The specific model numbers include: 3011642792, 3005334138, 3000215205, 1625425, 1000306431, 1016427, 3013666218, 1221485, 3015309643, 3001286223, 2182269, 3002755653, 3012536737, 3004111573, 1643817, 1820334, 3033589330, 3015225571, 4417, 3001595430, 1721504, 3009888344, 2183744, 3006950086, and 2126666. Always verify the correct model for your procedural setup.
How should the Fehling Biopsy Forceps be stored to maintain sterility?
The forceps must be stored in their original, sealed packaging until ready for use. They are supplied sterile, so the packaging should remain intact to prevent contamination. Store in a clean, dry environment away from direct sunlight or extreme temperatures. Never reuse or reprocess the device, as this could compromise sterility and patient safety. Follow all manufacturer guidelines for handling and disposal.
What regulatory pathway does the Fehling Biopsy Forceps follow?
The Fehling Biopsy Forceps are regulated under the FDA 510(k) clearance pathway, specifically with clearance number K170726. They are classified as Class II devices under the DWZ product code (Endomyocardial Biopsy Device). The device was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device. Always refer to the latest regulatory documentation for compliance.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K170726