Compass Steerable Needle
The Compass Steerable Needle CSN1001 is a sterile, single use biopsy needle for collecting tissue from within the lungs. Its 22 gauge needle is used through a compatible bronchoscope…
The Compass Steerable Needle CSN1001 is a sterile, single use biopsy needle for collecting tissue from within the lungs. Its 22 gauge needle is used through a compatible bronchoscope working channel.
A handle controls device rotation, advancement, retraction and bending of the distal shaft tip in one direction. A separate sampling mechanism extends and retracts the needle to obtain tissue, while a proximal luer connector accepts a stylet or aspiration syringe.
Listed Item
The Compass Steerable Needle (CSN) is sterile, single use, 22-gauge transbronchial needle with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions.
Bronchoscope Connection
The CSN1001 couples to specified Olympus 190 or Pentax bronchoscopes with a 2.0 mm working channel and 600 mm working length. It is packaged with a stylet and adapters. Its steerable tip articulates approximately 70 degrees in one plane.
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 | Serpex Medical, Inc., United States |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K221206 |
| Record published | 2023-03-17 |
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 | Storage environment temperature -30 to 60 °C |
| Sizes | Needle gauge 22 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSN1001 | Needle Gauge 22 G | In distribution |
| CSN1001 | 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 |
|---|---|
| K252874 | 2025-10-08 |
| K221206 | 2022-08-25 |
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.