Disposable Biopsy Refill Needle
by Suzhou Leapmed Healthcare Corporation
510(k) K212819
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212819 | Date6 Jul 2022 | 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- Withdrawn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, 1 Oct 2026
This device is a biopsy needle, classified as a disposable refill component for biopsy procedures. It is designed for obtaining tissue samples during diagnostic evaluations, commonly used in gastroenterology and urology. The needle facilitates precise tissue acquisition, aiding in the assessment of abnormalities such as tumors, cysts, or other pathological conditions in organs like the liver, kidney, or thyroid.
The disposable biopsy refill needle is intended for single-use and is supplied sterile for clinical procedures. It is regulated under FDA 510(k) clearance (K212819) and falls under device class II (FCG product code). No additional regulatory markings or MRI safety classifications are specified. The device is distributed in various reference codes, ensuring compatibility with existing biopsy systems. Storage and handling follow standard sterile medical device protocols.
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Questions
AI-generated answers, 1 Oct 2026
What is the disposable biopsy refill needle used for?
The disposable biopsy refill needle is designed for obtaining tissue samples during diagnostic evaluations, primarily in gastroenterology and urology. It aids in assessing abnormalities such as tumors, cysts, or other pathological conditions in organs like the liver, kidney, or thyroid. Its precision helps ensure accurate tissue acquisition for further pathological examination.
How is the disposable biopsy refill needle supplied and what are its sterility and usage guidelines?
The disposable biopsy refill needle is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of contamination or cross-infection. Following standard sterile medical device protocols during storage and handling is essential to maintain its integrity and effectiveness for clinical procedures.
Are there multiple models or reference codes available for this device?
Yes, the disposable biopsy refill needle is distributed in various reference codes (e.g., 3030447506, 1018233, etc.), ensuring compatibility with a range of existing biopsy systems. These reference codes allow clinicians to select the appropriate needle based on their specific procedural needs and equipment.
How should the disposable biopsy refill needle be stored?
The device should be stored according to standard sterile medical device protocols. This typically includes keeping it in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage ensures the needle remains sterile and functional until use.
What regulatory pathway does this device follow?
The disposable biopsy refill needle is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K212819. It is classified as a Class II device under the FCG product code, indicating it has undergone substantial equivalence review by the FDA for safety and performance.