Reusable Mlyocardial Biopsy Forceps (Bioptomes

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K890453 ↗

FDA Product Code

DWZ

Device Class

Class II

Regulation

21 CFR Part 870.4075

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• How is the Reusable Myocardial Biopsy Forceps (Bioptomes) intended to be used in clinical settings?

  The Reusable Myocardial Biopsy Forceps (Bioptomes) is designed for obtaining tissue samples from the heart muscle during endomyocardial biopsy procedures. It is intended for use by trained healthcare professionals in cardiovascular settings to help diagnose myocardial tissue conditions by facilitating tissue sampling for further pathological evaluation.

• Is the device meant for single-use or can it be reused between patients?

  While the device is labeled as reusable, it is explicitly intended for single-use per procedure to ensure sterility and safety. Between uses, it must undergo proper sterilization and storage protocols as outlined by the manufacturer to maintain its integrity and prevent cross-contamination.

• What storage and handling requirements should be followed for this device?

  The device is supplied sterile, but since it is reusable, it requires strict adherence to sterilization protocols between uses. It is not MRI-safe, so it must be stored and handled in a way that avoids exposure to MRI environments. Proper storage conditions, as specified by the manufacturer, should be followed to preserve its functionality and sterility.

• What regulatory pathway was followed for FDA clearance of this device?

  The Reusable Myocardial Biopsy Forceps (Bioptomes) received FDA clearance through a Traditional 510(k) pathway under the Cardiovascular Advisory Committee. The clearance (K890453) was granted in 1989, with the device classified as substantially equivalent to a predicate under FDA regulation 870.4075 and assigned product code DWZ.