Morrison Steerable Needle
by Apriomed AB
510(k) K150625
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150625 | Date9 Jun 2015 | StatusActive |
Official records
- FDA 510(k) database K150625
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNW
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Morrison Steerable Needle is a fine-needle aspiration (FNA) biopsy needle designed for precise, steerable access to deep-seated targets within the body. Its flexible, steerable design enables real-time navigation under imaging guidance, allowing clinicians to navigate around anatomical obstacles or sensitive structures during procedures.
This device is supplied as a single-use, sterile needle in a 21-gauge configuration, intended for use in interventional radiology, gastroenterology, and urology settings. It is approved for aspiration, injection, and biopsy applications, with FDA 510(k) clearance (K150625) under the Gastroenterology and Urology advisory committees. Compatibility with imaging modalities ensures accurate placement during live feedback-guided procedures.
Devices cleared under K150625
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Morrison Steerable Needle 13550 | 13550 / 13550 | 07350031355505 | Length 17 cm; Needle Gauge 21 G | On the market |
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