Biopty-CUT
BIOPTY-CUT® Disposable Core Biopsy Needle with Spacer, 14g x 20cm
3manufacturers in China registered for this device type
10catalogue numbers in this listing
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Bard Peripheral Vascular, Inc., United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-13 |
| Record revised | 2024-08-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Needle gauge 14 to 20 G; length 10 to 20 cm |
| Distribution end date | 2023-03-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 441610 | Needle Gauge 16 G | Withdrawn |
| 451420 | Length 20 cm | Withdrawn |
| 451816 | Needle Gauge 18 G | Withdrawn |
| 451410 | Needle Gauge 14 G | Withdrawn |
| 452020 | Needle Gauge 20 G | Withdrawn |
| 441416 | Length 16 cm | Withdrawn |
| 441410 | Length 10 cm | Withdrawn |
| 452016 | Needle Gauge 20 G | Withdrawn |
| 141410 | Length 10 cm | Withdrawn |
| 441816 | Length 16 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
Showing 12 of 115. All products under Biopsy Needle
Recalls
3 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 |
|---|---|---|---|---|---|
| 2024-08-02 | Class II | Packaging change control | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised. | 60 (U.S.) and 5,160 (O.U.S.) | |
| 2016-07-06 | Class II | Packaging | May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. | 1250 units | 2016-11-17 |
| 2016-02-04 | Class II | Unknown/Undetermined by firm | Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial. | 2320 units | 2016-08-03 |
| 2009-10-08 | Not classified | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample c | 127,169 units | 2012-04-02 |
| 2009-10-08 | Not classified | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample c | 77, 848 units | 2012-04-02 |
| 2009-10-08 | Not classified | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample c | 32, 427 units | 2012-04-02 |
| 2009-10-08 | Not classified | Process design | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample c | 97, 257 units | 2012-04-02 |
| 2006-05-01 | Not classified | Other | Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected. | 225 | 2012-04-24 |
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.