Sertera Biopsy Device
Sertera Biopsy Device is a disposable spring-loaded instrument for obtaining percutaneous core samples from soft tissue and breast tumors. It is handheld and can be operated with one hand,…
Sertera Biopsy Device is a disposable spring-loaded instrument for obtaining percutaneous core samples from soft tissue and breast tumors. It is handheld and can be operated with one hand, with 12 gauge and 14 gauge needle versions.
An inner needle with a side aperture penetrates the tissue. A sharpened outer cannula then advances over the aperture to cut the tissue sample, using the spring-loaded mechanism.
Listed Item
14 GA Sertera Spring Loaded Core Device
Breast Sampling
The device is used primarily for ultrasound-guided breast biopsy. Breast use is diagnostic, and the device is not intended for bone sampling. A physician targets the region of interest after local preparation and needle introduction.
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K150169 |
| Record published | 2015-12-14 |
| Record revised | 2024-04-11 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sertera-14 | In distribution | |
| Sertera-14 | In distribution | |
| Sertera-12 | In distribution | |
| Sertera-12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | 157 |
| CorVocet™ | Merit Medical Systems, Inc. | 157 |
| SureCore Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 108 |
| M Biopsy Coaxial Biopsy Needle | Canyon Medical Inc. | 89 |
| Co-Axial Introducer Needle | Argon Medical Devices, Inc. | 80 |
| SureCore Semi-automatic Disposable Biopsy Needle | Canyon Medical Inc. | 76 |
| Invivo | Philips DS North America LLC | 71 |
| Coaxial needle | Möller Medical GmbH | 68 |
| Disposable needle for reusable biopsy gun | Möller Medical GmbH | 62 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 60 |
Showing 12 of 692. All products under Instrument, Biopsy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262792 | 2026-08-12 |
| K180233 | 2018-04-10 |
| K163052 | 2017-03-29 |
| K150169 | 2015-08-14 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Hologic, Inc. | 510(k) number | 2025-01-15 | Class II | Process control | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. | 55,335 units | |
| Hologic, Inc. | 510(k) number | 2023-05-02 | Class II | Device Design | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery | 756 units | |
| Hologic, Inc. | 510(k) number | 2016-08-22 | Class II | Labeling Change Control | Incorrect label on the Sertera Biopsy Kit | 570 units | 2017-02-03 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-12-15 | Class II | Under Investigation by firm | Presence of particulates in affected devices that can be deposited into breast tissue during use. | 681,870 units | |
| 2010-08-11 | Not classified | Packaging | The firm received a customer complaint that the a device labeled as ATEC 0912-12 was actually ATEC 0912-20. | 990 | 2011-04-13 |
| 2010-02-01 | Not classified | Employee error | The product is labeled as ATEC0909-12 but it actually contains 0909-20. | 190 | 2010-10-08 |
| 2008-09-22 | Not classified | Process control | The distal tip of the needle may become detached and remain in the patient, requiring surgical removal. | 5,120 (1,024 cases of 5) | 2009-11-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.