ClearView
ClearView Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath Diameter 1.8 mm, beveled stylet
3manufacturers in China registered for this device type
7catalogue numbers in this listing
7510(k) clearances naming this product 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 | Medi-Globe Gmbh, Germany |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Sizes | Needle gauge 19 to 25 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CV2119R | Needle Gauge 19 G | In distribution |
| CV1822EB | Needle Gauge 22 G | In distribution |
| CV1822R | Needle Gauge 22 G | In distribution |
| CV2722EB | Needle Gauge 22 G | In distribution |
| CV2725R | Needle Gauge 25 G | In distribution |
| CV2722R | Needle Gauge 22 G | In distribution |
| CV1825R | Needle Gauge 25 G | 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 |
|---|---|
| K133763 | 2014-05-15 |
| K091257 | 2009-05-08 |
| K083802 | 2009-03-20 |
| K070129 | 2007-01-31 |
| K051247 | 2005-06-16 |
| K990220 | 1999-03-31 |
| K935844 | 1995-02-13 |
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.