Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
by Guangzhou Shengwei Medical Devices Co., Ltd.
510(k) K214063
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK214063 | Date3 Jun 2022 | 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- Withdrawn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, 6 Oct 2026
The device is a biopsy needle intended for use in soft tissue core biopsy procedures. It is not intended for use in bone.
The device is supplied as a disposable coaxial biopsy needle (Model 131) and standard biopsy needles (Models 111, 112, 121). It has received FDA 510(k) clearance (K214063) and is classified as a Class II medical device under product code KNW.
Other devices from Guangzhou Shengwei Medical Devices Co., Ltd.
Questions
AI-generated answers, 6 Oct 2026
What is the Model 121 Biopsy Needle used for?
The Model 121 Biopsy Needle is intended for use in soft tissue core biopsy procedures, as stated in the device description, and is not intended for use in bone tissue.
How is the Model 131 Disposable Coaxial Biopsy Needle supplied?
The Model 131 Disposable Coaxial Biopsy Needle is supplied as a disposable device, meaning it is intended for single-use only and is not designed for reuse after a procedure.
Are the Models 111, 112, and 121 Biopsy Needles reusable?
The Models 111, 112, and 121 Biopsy Needles are supplied as standard biopsy needles and are intended for single-use only, consistent with the disposable nature of the device family described in the data.
What regulatory pathway was used for the Model 121 Biopsy Needle and related models?
The device received FDA 510(k) clearance under K214063, indicating it was cleared through the traditional 510(k) process as substantially equivalent to a predicate device.