Biopsybell
Semiautomatic guillotine needle for soft-tissue biopsy
3manufacturers in China registered for this device type
227catalogue 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 | 2023-09-04 |
| Record revised | 2023-06-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 5 to 30 °C |
| Packaging | Blister of 5 |
| Sizes | Length 70 to 470 mm; needle gauge 8 to 21 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 200 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 18 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 16 G | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 19 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL | Length 470 mm | In distribution |
| ESTER & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| ESTER ONE SHOT | Length 150 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 16 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| ESTER & INTRODUTTORE | Length 200 mm | In distribution |
| ESTER | Length 100 mm | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 100 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 20 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| ESTER & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 19 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 19 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| ESTER | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 70 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 18 G | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| ESTER ONE SHOT | Length 250 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| ESTER ONE SHOT | Length 200 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| ESTER & INTRODUTTORE | Length 150 mm | In distribution |
| ESTER ONE SHOT | Length 100 mm | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
| ESTER ONE SHOT | Length 200 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 300 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| ESTER | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 130 mm | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 20 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 17 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 200 mm | In distribution |
| ESTER | Length 100 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 18 G | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 20 G | In distribution |
| ESTER ONE SHOT | Length 250 mm | In distribution |
| ESTER & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 17 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 18 G | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 18 G | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 130 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 70 mm | In distribution |
| ESTER | Length 300 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 19 G | In distribution |
| ESTER ONE SHOT | Length 150 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 20 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 100 mm | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| ESTER ONE SHOT | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 18 G | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 18 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 21 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 17 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 21 G | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 20 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 21 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 130 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| OSTEOBELL EXPLANT | Length 190 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| ESTER ONE SHOT | Length 200 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 16 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 300 mm | In distribution |
| ESTER ONE SHOT | Length 100 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 20 G | In distribution |
| ESTER ONE SHOT | Length 100 mm | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 18 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 150 mm | In distribution |
| ESTER ONE SHOT | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 17 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 300 mm | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 16 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 21 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 20 G | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 200 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| ESTER | Length 150 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 20 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 17 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 21 G | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 250 mm | In distribution |
| SPEEDYBELL | Length 470 mm | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL | Length 300 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 200 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Needle Gauge 20 G | In distribution |
| Ester one shot | Length 150 mm | In distribution |
| ESTER ONE SHOT | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 70 mm | In distribution |
| ESTER ONE SHOT | Length 250 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 16 G | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 100 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA | Length 150 mm | In distribution |
| ESTER & INTRODUTTORE | Needle Gauge 18 G | In distribution |
| SPEEDYBELL | Length 100 mm | In distribution |
| SPEEDYBELL | Length 200 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 150 mm | In distribution |
| SPEEDYBELL | Length 130 mm | In distribution |
| SPEEDYBELL & INTRODUTTORE | Length 130 mm | In distribution |
| ESTER | Length 200 mm | In distribution |
| OSTEOBELL EXPLANT | Length 150 mm | In distribution |
| ESTER | Length 100 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL | Length 250 mm | In distribution |
| SPEEDYBELL | Length 70 mm | In distribution |
| SPEEDYBELL DOPPIA CORSA & INTRODUTTORE | Length 70 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 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.