Identifiers
- 510(k) Number
- K140137 FDA 510(k)
- FDA Product Code
- FCG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1075 FDA 510(k)
- Regulation Number
- 876.1075 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Safety Biopsy Needle System is a biopsy needle device classified under product code FCG and regulation number 876.1075. It is substantially equivalent to a predicate device and has received traditional 510(k) clearance from the FDA. The device is intended for use in gastroenterology and urology procedures.
The system includes a safety biopsy needle and a safety coaxial needle with finger guard. It is designed for soft tissue and tumor biopsy of organs such as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. The device is supplied non-sterile and is intended for single use. Storage and handling should follow manufacturer guidelines. Authorization is based on FDA 510(k) clearance K140137.
Frequently asked questions
What is the Safety Biopsy Needle System used for?
The Safety Biopsy Needle System is intended for soft tissue and tumor biopsy of organs such as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes in gastroenterology and urology procedures, as stated in the device description.
Is the Safety Biopsy Needle System sterile or non-sterile when supplied?
The device is supplied non-sterile, as explicitly mentioned in the description, and is intended for single use only.
Can the Safety Biopsy Needle System be reused after a procedure?
No, the Safety Biopsy Needle System is designed for single use only, as specified in the device description, and should not be reused to ensure patient safety and device integrity.
What components are included in the Safety Biopsy Needle System?
The system includes a safety biopsy needle and a safety coaxial needle with finger guard, as detailed in the device description under the system components.
How should the Safety Biopsy Needle System be stored and handled?
Storage and handling should follow the manufacturer's guidelines, as noted in the device description, to maintain device performance and safety prior to use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Safety-Biopsy ASEPT Safety-Biopsy- System - pfmmedical.com, Safety Biopsy Needle System 510 (k) FDA Premarket Notification K140137 ..., Pfm Medical, Inc. FDA 510 (k) Products - Latest 2025, SAFETY BIOPSY NEEDLE SYSTEM (K140137) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140137 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pfm Medical, Inc.
Sources (1)
- FDA 510(k) K140137 24 fields · synced Sep 25, 2026