Somatex
7 catalogue numbers from SOMACORE VERIFY, listed by Biopsybell SRL, under Biopsy Needle. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
7catalogue 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 | Biopsybell SRL |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K130616 |
| Record published | 2016-08-01 |
| Record revised | 2025-04-29 (version 5) |
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 |
| Packaging | Pack of 5 |
| Sizes | Needle gauge 14 to 20 G; length 100 to 150 mm |
| Distribution end date | 2025-04-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SOMACORE VERIFY | Needle Gauge 14 G | Withdrawn |
| SOMACORE VERIFY | Length 100 mm | Withdrawn |
| SOMACORE VERIFY S | Length 150 mm | Withdrawn |
| SOMACORE VERIFY S | Length 100 mm | Withdrawn |
| SOMACORE VERIFY S | Length 150 mm | Withdrawn |
| SOMACORE VERIFY | Needle Gauge 16 G | Withdrawn |
| SOMACORE VERIFY | Length 150 mm | Withdrawn |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 |
| 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 |
|---|---|---|---|---|---|---|---|
| Biopsybell S.R.L. | 510(k) number | 2021-03-22 | Class II | Vendor change control | Products labeled as sterile were distributed, but may not have been sterilized. | 50 units | 2026-02-17 |
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.