Global Medical Cutting Biopsy Needle
510(k) K934256
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934256 | Date28 Mar 1994 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- FCG
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy.
The device is supplied as a sterile, single-use instrument. It is indicated for use in gastroenterology and urology procedures to obtain tissue specimens. The device has received FDA 510(k) clearance under product code FCG and regulation number 876.1075, and is classified as a Class II medical device.
Other devices from Global Medical Prods, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the GLOBAL MEDICAL CUTTING BIOPSY NEEDLE used for?
It is used to obtain tissue specimens in gastroenterology and urology procedures by cutting or aspiration for microscopic examination, as indicated in its device description.
How is the GLOBAL MEDICAL CUTTING BIOPSY NEEDLE supplied and is it reusable?
The device is supplied as a sterile, single-use instrument, meaning it is intended for one procedure only and must be discarded after use to maintain sterility and prevent cross-contamination.
What regulatory pathway was used for the GLOBAL MEDICAL CUTTING BIOPSY NEEDLE?
It received FDA 510(k) clearance under k-number K934256, with a traditional submission path and a substantially equivalent decision, as shown in the authorization and decision fields.