Soft Tissue Biopsy Needle
by Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) K870785
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870785 | Date1 Apr 1987 | 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- Withdrawn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
- KNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Soft Tissue Biopsy Needle is a device used for biopsy procedures, specifically for obtaining tissue samples from soft tissue. It is designed to facilitate the collection of tissue samples for further examination. The device is classified under the product code KNW. The Soft Tissue Biopsy Needle is a medical instrument used in various clinical settings.
The Soft Tissue Biopsy Needle is supplied by Bd Becton Dickinson Vacutainer Systems Preanalytic. It has been authorized with an FDA 510K clearance, with a decision description of Substantially Equivalent. The device is associated with the advisory committees Gastroenterology and Urology. The Soft Tissue Biopsy Needle has a specific k number, K870785, and is classified under the product code KNW.
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Questions
AI-generated answers, 23 Sep 2026
What is the Soft Tissue Biopsy Needle used for?
The Soft Tissue Biopsy Needle is used for biopsy procedures to obtain tissue samples from soft tissue for further examination.
Is the Soft Tissue Biopsy Needle supplied sterile?
The description does not specify if the Soft Tissue Biopsy Needle is supplied sterile, but it is designed for use in clinical settings where sterility is crucial.
What is the regulatory status of the Soft Tissue Biopsy Needle?
The Soft Tissue Biopsy Needle has been authorized with an FDA 510K clearance, with a decision description of Substantially Equivalent, under the product code KNW.