SemiCut Coax.
DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 200 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER, WITH INTRODUCERR
3manufacturers in China registered for this device type
22catalogue numbers in this listing
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 | M.D.L. S.R.L., Italy |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K160316 |
| Record published | 2021-04-26 |
| Record revised | 2021-05-27 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Needle gauge 14 to 20 G; length 70 to 250 mm |
| Distribution end date | 2021-04-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PD0PP1615 | Needle Gauge 16 G | In distribution |
| PD0PP1810 | Length 100 mm | In distribution |
| PD0PP1816 | Needle Gauge 18 G | In distribution |
| PD0PP1416 | Length 160 mm | In distribution |
| PD0PP1820 | Length 200 mm | In distribution |
| PD0PP2016 | Length 160 mm | In distribution |
| PD0PP1420 | Needle Gauge 14 G | In distribution |
| PD0PP1610 | Length 100 mm | In distribution |
| PD0PP1415 | Needle Gauge 14 G | In distribution |
| PD0PP2010 | Length 100 mm | In distribution |
| PD0PP1616 | Needle Gauge 16 G | In distribution |
| PD0PP1825 | Needle Gauge 18 G | In distribution |
| PD0PP2007 | Needle Gauge 20 G | In distribution |
| PD0PP2020 | Needle Gauge 20 G | In distribution |
| PD0PP1807 | Needle Gauge 18 G | In distribution |
| PD0PP1620 | Length 200 mm | In distribution |
| PD0PP1410 | Needle Gauge 14 G | In distribution |
| PD0PP1407 | Needle Gauge 14 G | In distribution |
| PD0PP1807 | Withdrawn | |
| PD0PP1415 | Withdrawn | |
| PD0PP1407 | Withdrawn | |
| PD0PP1615 | Withdrawn |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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| M.D.L. S.R.L. | 510(k) number | 2021-08-05 | Class II | Other | Sterility assurance may be compromised. | 20,129 units | 2026-05-04 |
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.