Interject
Injection Therapy Needle Catheter
3manufacturers in China registered for this device type
10catalogue numbers in this listing
5510(k) clearances naming this product code
24recalls on this code
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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00518260 | 25 ga Diameter | In distribution |
| M00518360 | 240 cm Effective Length | In distribution |
| M00518300 | 23 ga Diameter | In distribution |
| M00518100 | 23 ga Diameter | In distribution |
| M00518350 | 0.6 mm Diameter | In distribution |
| M00518250 | 0.6 mm Diameter | In distribution |
| M00518150 | 0.6 mm Diameter | In distribution |
| M00518310 | 25 ga Diameter | In distribution |
| M00518160 | 0.5 mm Diameter | In distribution |
| M00518110 | 200 cm Effective Length | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151895 | 2015-10-22 |
| K100712 | 2010-03-30 |
| K050120 | 2005-02-08 |
| K040893 | 2004-05-06 |
| K012864 | 2001-10-24 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-08-11 | Not classified | Other | The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga. | 30 units | 2011-11-10 |
| 2010-10-20 | Not classified | Other | The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle. | 567 all products | 2011-08-03 |
| 2010-10-20 | Not classified | Other | The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle. | 567 all products | 2011-08-03 |
| 2010-10-20 | Not classified | Other | The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle. | 567 all products. | 2011-08-03 |
| 2010-10-20 | Not classified | Other | The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle. | 567 all products | 2011-08-03 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 430 of both systems. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 430 of both systems. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-17 | Not classified | Nonconforming Material/Component | These devices may experience difficulty cocking and arming, resulting in an inability to use the devices. | 14,254 of all devices. | 2009-12-15 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
| 2008-10-07 | Not classified | Device Design | Boston Scientific Corporation initiated a recall of its easy Core” BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | 3808 total for all products | 2011-12-10 |
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.