Techna-Cut Aspiration Needle
by Medical Device Technologies, Inc.
510(k) K974766
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974766 | Date8 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Manan Techna-Cut Aspiration Needle
- 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, 1 Oct 2026
The Techna-Cut Aspiration Needle is a manual surgical instrument designed for obtaining tissue samples through aspiration. It employs a Menghini cutting tip geometry to excise biopsy material from soft tissues. This device is classified under the product code KNW, falling within the categories of gastroenterology and urology. Its primary function is to facilitate precise tissue acquisition for diagnostic purposes.
Used in clinical settings, the Techna-Cut Aspiration Needle is supplied with a locking syringe for aspiration and is intended for single-use. The device is regulated under the FDA’s 510(k) clearance pathway, specifically through the Traditional 510(k) process, with a clearance date of January 8, 1998. No information regarding sterility, MRI safety, or reusable status is provided in the available data.
Other devices from Medical Device Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Techna-Cut Aspiration Needle used for?
The Techna-Cut Aspiration Needle is designed specifically for obtaining tissue samples through aspiration, particularly in soft tissues. Its Menghini cutting tip geometry allows for precise excision of biopsy material, making it ideal for diagnostic procedures in urology and gastroenterology. This ensures accurate sample acquisition for further pathological examination.
How is the Techna-Cut Aspiration Needle supplied?
The device is supplied pre-packaged with a locking syringe, which facilitates the aspiration process during tissue sampling. This combination ensures ease of use and proper handling during clinical procedures. The syringe is integrated to maintain a secure seal and control during the biopsy.
Is the Techna-Cut Aspiration Needle intended for single-use or reuse?
The Techna-Cut Aspiration Needle is explicitly intended for single-use only. This design choice aligns with best practices for infection control and sterility, reducing the risk of cross-contamination between patients. Single-use devices are also easier to track and manage in clinical settings.
What are the key distinguishing features of the Techna-Cut Aspiration Needle?
The needle’s primary distinguishing feature is its Menghini cutting tip geometry, which enhances precision during tissue excision. It is classified under product code KNW, indicating its use in gastroenterology and urology. Additionally, it is supplied with a locking syringe, which aids in controlled aspiration and sample retrieval.
How should the Techna-Cut Aspiration Needle be stored?
While specific storage instructions are not detailed in the provided data, standard practices for single-use surgical instruments should be followed. The device should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Ensure the packaging remains intact until immediate use to maintain sterility and functionality.