Themy
THEMY AUTOMATIC NEEDLE 18Gx250mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY OF 5 PCS
3manufacturers in China registered for this device type
61catalogue 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 | 2021-05-17 |
| Record revised | 2021-05-27 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 50 °C |
| Packaging | Pack of 5 |
| Sizes | Needle gauge 12 to 20 G; length 60 to 250 mm |
| Distribution end date | 2021-05-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TY1412 | Needle Gauge 14 G | In distribution |
| TY1812 | Length 120 mm | In distribution |
| TY2016 | Length 160 mm | In distribution |
| TY1820 | Needle Gauge 18 G | In distribution |
| TY1416 | Needle Gauge 14 G | In distribution |
| TY1612 | Needle Gauge 16 G | In distribution |
| TYC2010 | Needle Gauge 20 G | In distribution |
| TYC2016 | Length 160 mm | In distribution |
| TYC1820 | Needle Gauge 18 G | In distribution |
| TYC2020 | Length 200 mm | In distribution |
| TYC1810 | Length 100 mm | In distribution |
| TY1816 | Length 160 mm | In distribution |
| TY1209 | Needle Gauge 12 G | In distribution |
| TYC1412 | Needle Gauge 14 G | In distribution |
| TY2010 | Needle Gauge 20 G | In distribution |
| TYC1825 | Length 250 mm | In distribution |
| TYC1816 | Needle Gauge 18 G | In distribution |
| TYC1416 | Needle Gauge 14 G | In distribution |
| TY1616 | Needle Gauge 16 G | In distribution |
| TY1211 | Length 110 mm | In distribution |
| TY1206 | Length 60 mm | In distribution |
| TYC1410 | Length 100 mm | In distribution |
| TY2020 | Needle Gauge 20 G | In distribution |
| TY1420 | Needle Gauge 14 G | In distribution |
| TY1620 | Length 200 mm | In distribution |
| TY1610 | Length 100 mm | In distribution |
| TY1810 | Needle Gauge 18 G | In distribution |
| TYC1812 | Length 120 mm | In distribution |
| TY1410 | Length 100 mm | In distribution |
| TY1825 | Length 250 mm | In distribution |
| TY1616 | Needle Gauge 16 G | Withdrawn |
| TY1612 | Withdrawn | |
| TY1412 | Needle Gauge 14 G | Withdrawn |
| TYC1825 | Length 250 mm | Withdrawn |
| TY2020 | Needle Gauge 20 G | Withdrawn |
| TYC1416 | Needle Gauge 14 G | Withdrawn |
| TY2010 | Needle Gauge 20 G | Withdrawn |
| TY1610 | Length 100 mm | Withdrawn |
| TYC1820 | Needle Gauge 18 G | Withdrawn |
| TYC1810 | Length 100 mm | Withdrawn |
| TY1812 | Length 120 mm | Withdrawn |
| TY1209 | Withdrawn | |
| TYC1412 | Needle Gauge 14 G | Withdrawn |
| TY2016 | Length 160 mm | Withdrawn |
| TY1816 | Length 160 mm | Withdrawn |
| TY1420 | Needle Gauge 14 G | Withdrawn |
| TY1820 | Needle Gauge 18 G | Withdrawn |
| TY1620 | Length 200 mm | Withdrawn |
| TY1810 | Needle Gauge 18 G | Withdrawn |
| TYC1816 | Needle Gauge 18 G | Withdrawn |
| TY1416 | Needle Gauge 14 G | Withdrawn |
| TYC1410 | Length 100 mm | Withdrawn |
| TY1211 | Withdrawn | |
| TYC2020 | Length 200 mm | Withdrawn |
| TY1206 | Withdrawn | |
| TYC2016 | Needle Gauge 20 G | Withdrawn |
| TY1825 | Length 250 mm | Withdrawn |
| TY1410 | Length 100 mm | Withdrawn |
| TYC2010 | Length 100 mm | Withdrawn |
| TYC1812 | Length 120 mm | Withdrawn |
| TY1610 | Length 100 mm | 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 |
| 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 |
| SemiCut Coax. | M.D.L. S.R.L. | 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.