EndoCore
The FDA filing identifies Praxis Medical EndoCore as a device used with an ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. Its…
The FDA filing identifies Praxis Medical EndoCore as a device used with an ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.
Its indications cover patients 18 years and older who require tissue sampling. The device description says it is used with endoscopes for ultrasound-guided fine-needle aspiration and fine-needle biopsy.
Device Description and Stated Use
The summary describes an internal motor that rotates the needle to facilitate collection of cellular material.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Praxis Medical LLC, United States |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K230778 |
| Record published | 2025-11-06 |
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 |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EndoCore | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope Accessory | Richard Wolf Gmbh | 42 |
| MultiStage® | Dongguan TT Medical, Inc. | 24 |
| Elation™ | Merit Medical Systems, Inc. | 23 |
| Inspira AIR | Acclarent, Inc. | 14 |
| Texas | Richard Wolf Gmbh | 10 |
| Trachealator Non-occlusive Airway Dilation Balloon | Disa Medinotec (PTY) Ltd | 9 |
| Pilling | Teleflex Medical LLC | 8 |
| CRE Pulmonary | Boston Scientific Corporation | 6 |
| Single Use Aspiration Needle | Olympus Medical Systems Corp. | 5 |
| Cook | Cook Incorporated | 3 |
| Areus(TM) Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Trident(TM) Endobronchial Ultrasound Biopsy Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
Showing 12 of 37. All products under Bronchoscope Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230778 | 2023-09-25 |
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.