Beacon
EUS Access System Preloaded 18.5 G Access Needle 0.035 Inch Guidewire Compatible
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 | Covidien LP, United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K180037 |
| Record published | 2020-01-10 |
| Record revised | 2025-12-03 (version 9) |
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 |
| Storage | Special storage condition: Keep dry |
| Packaging | Pack_or_inner_pack of 5 |
| Sizes | Needle gauge 19 to 25 G; angle 90 to 135 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSA-135-01 | Angle 135 ° | In distribution |
| DSN-25-01 | Needle Gauge 25 G | In distribution |
| DSN-22-01 | Needle Gauge 22 G | In distribution |
| N-22-05 | Needle Gauge 22 G | In distribution |
| DSA-090-01 | Angle 90 ° | In distribution |
| N-19-05 | Working Length,1663,Millimeter;Minimum Catheter Size ID,1.9,Millimeter; | In distribution |
| DSN-19-01 | Working Length,1380-1430,Millimeter;Minimum Channel Size,2.8,Millimeter; | In distribution |
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
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2020-06-26 | Class II | Under Investigation by firm | This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detach | 375 units | |
| Covidien | 510(k) number | 2020-06-26 | Class II | Under Investigation by firm | This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detach | 269 units | |
| Covidien | 510(k) number | 2017-02-08 | Class II | Nonconforming Material/Component | Handle may break during use. | 1,096 Units (total for all products) | 2019-07-18 |
| Covidien | 510(k) number | 2017-02-08 | Class II | Nonconforming Material/Component | Handle may break during use. | 1,096 Units (total for all products) | 2019-07-18 |
| Covidien | 510(k) number | 2017-02-08 | Class II | Nonconforming Material/Component | Handle may break during use. | 1,096 Units (total for all products) | 2019-07-18 |
| Covidien | 510(k) number | 2017-02-08 | Class II | Nonconforming Material/Component | Handle may break during use. | 1,096 Units (total for all products) | 2019-07-18 |
| Covidien | 510(k) number | 2017-02-08 | Class II | Nonconforming Material/Component | Handle may break during use. | 1,096 Units (total for all products) | 2019-07-18 |
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.