Finesse®
FINESSE® Ultra 14 Breast Biopsy Probe, 14G x 105mm
9manufacturers in China registered for this device type
4catalogue numbers in this listing
8510(k) clearances naming this product code
27recalls on this code
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 | Bard Peripheral Vascular, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K093068 |
| Record published | 2016-09-20 |
| Record revised | 2024-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 5 |
| Sizes | Length 105 mm; needle gauge 10 to 14 G |
| Distribution end date | 2022-10-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FS10105 | Length 105 mm | Withdrawn |
| F14105US | Needle Gauge 14 G | Withdrawn |
| F01BLU | Withdrawn | |
| FS14105 | Needle Gauge 14 G | Withdrawn |
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 |
|---|---|
| K262571 | 2026-08-14 |
| K252681 | 2025-12-12 |
| K250032 | 2025-07-10 |
| K213896 | 2022-03-30 |
| K211933 | 2021-07-15 |
| K192948 | 2019-11-07 |
| K171953 | 2017-09-14 |
| K133948 | 2014-02-21 |
Recalls
26 of these are 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 |
|---|---|---|---|---|---|
| 2024-09-30 | Class II | Process change control | Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacemen | 71,498 | |
| 2023-11-08 | Class II | Process control | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit prope | 1,243,937 | |
| 2023-08-10 | Class II | Device Design | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial c | 1,545 | |
| 2023-04-11 | Class II | Mixed-up of materials/components | Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, w | 4,120 | |
| 2023-02-28 | Class II | Mixed-up of materials/components | The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatib | 38,635 | |
| 2021-08-24 | Class II | Process control | Due to misbranded products shipped to customers. | 360 devices | 2024-12-23 |
| 2021-08-24 | Class II | Process control | Due to misbranded products shipped to customers. | 360 devices | 2024-12-23 |
| 2021-06-23 | Class II | Packaging process control | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. | 1,200 device | |
| 2021-06-23 | Class II | Packaging process control | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. | 560 devices | |
| 2021-06-23 | Class II | Packaging process control | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. | 3,961 devices | |
| 2021-01-14 | Class II | Process control | Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use. | Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S. | 2025-01-28 |
| 2020-03-17 | Class II | Packaging process control | Sterility compromised due to packaging pouches that may not be sealed properly | 8,170 units (US: 420 and OUS: 7,750) | 2024-07-15 |
| 2020-01-03 | Class II | Component change control | Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples. | 1,585 units | 2022-03-17 |
| 2020-01-03 | Class II | Component change control | Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples. | 1,085 units | 2022-03-17 |
| 2020-01-03 | Class II | Component change control | Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples. | 2,050 units | 2022-03-17 |
| 2020-01-03 | Class II | Component change control | Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples. | 12,875 units | 2022-03-17 |
| 2019-10-25 | Class II | Equipment maintenance | During the firm’s review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples. | 727,034 units | 2024-04-12 |
| 2019-05-02 | Class II | Component change control | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | 29,918 units | 2022-03-03 |
| 2019-05-02 | Class II | Component change control | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | 125,292 units | 2022-03-03 |
| 2019-05-02 | Class II | Component change control | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | 239 units | 2022-03-03 |
| 2019-05-02 | Class II | Component change control | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | 36,640 units | 2022-03-03 |
| 2019-05-02 | Class II | Component change control | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | 12,833 units | 2022-03-03 |
| 2019-05-02 | Class II | Component change control | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | 5,298 units | 2022-03-03 |
| 2017-09-22 | Class II | Device Design | During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation. | 110,550 units | 2018-09-27 |
| 2015-04-09 | Class II | Process design | The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues. | 7,995 units | 2015-09-25 |
| 2015-03-17 | Class II | Nonconforming Material/Component | Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues. | 29,342 units | 2015-08-03 |
| 2008-09-12 | Not classified | Device Design | Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option. | 225 | 2012-09-19 |
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.