EchoTip
EchoTip Ultra, Endobronchial High Definition Ultrasound Needle
3manufacturers in China registered for this device type
8catalogue 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 | Cook Ireland Ltd, Ireland |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2026-03-25 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store the device in a dry location |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G31518 | In distribution | |
| G31519 | In distribution | |
| G53408 | In distribution | |
| G24061 | In distribution | |
| G31520 | In distribution | |
| G52011 | In distribution | |
| G24062 | In distribution | |
| G52012 | 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 |
|---|---|
| K241209 | 2024-07-29 |
| K230909 | 2023-05-30 |
| K210476 | 2021-05-20 |
| K160229 | 2016-03-21 |
| K142688 | 2014-12-19 |
| K093195 | 2010-01-21 |
| K092359 | 2009-11-02 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2024-04-01 | Class II | Nonconforming Material/Component | Devices may contain elevated levels of bacterial endotoxin. | 1 Unit OUS |
| Cook Incorporated | UDI-DI | 2024-04-01 | Class II | Nonconforming Material/Component | Devices may contain elevated levels of bacterial endotoxin. | 8 units OUS |
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.