En-Bloc Biopsy System Modification
510(k) K052246
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052246 | Date22 Aug 2005 | 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- Withdrawn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
- Modification to En-Bloc Biopsy System
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The En-Bloc Biopsy System Modification is a vacuum-assisted electrosurgical device designed for percutaneous, automated tissue removal. It combines electrosurgical cutting with simultaneous capture of excised tissue volumes, enabling precise en-bloc resection. This modification builds upon an existing system to enhance procedural efficiency for soft tissue extraction. The device is classified under General and Plastic Surgery (Product Code: GEI) and is intended for use in controlled clinical settings requiring tissue sampling or excision.
The system consists of a reusable hand-held biopsy handle and a single-use en-bloc biopsy probe, connected via an integral cable to a control unit. It is supplied sterile for single-use applications and requires no special MRI safety considerations. Available probe sizes include 10mm, 12mm, 15mm, and 20mm, as referenced in the original cleared device specifications. Authorized for use in the United States under an FDA 510(k) clearance (K052246), the modification was reviewed by the Surgical Devices Panel (SU) and deemed substantially equivalent to prior-generation devices.
Other devices from Neothermia Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the En-Bloc Biopsy System Modification used for?
This modification enhances the original En-Bloc Biopsy System by automating tissue removal through electrosurgical cutting and simultaneous vacuum-assisted capture. It is designed for percutaneous, en-bloc resection of soft tissue samples or excisions in clinical settings where precise, controlled tissue extraction is required. The system improves procedural efficiency compared to manual techniques by enabling automated, cohesive tissue removal.
How is the En-Bloc Biopsy System Modification supplied and prepared for use?
The system is supplied sterile for single-use applications. It includes a reusable hand-held biopsy handle, a single-use en-bloc biopsy probe (connected via an integral cable to a control unit), and no additional preparation is required beyond standard sterile field protocols. The probe sizes (10mm, 12mm, 15mm, and 20mm) are pre-sterilized and ready for immediate use after opening.
Are the biopsy probes reusable or single-use, and how should they be handled?
The biopsy probes are designed for single-use only. After use, they must be discarded in accordance with medical waste disposal guidelines to maintain sterility and prevent cross-contamination. The reusable hand-held biopsy handle and control unit require cleaning and maintenance as specified in the manufacturer’s instructions for reuse.
What probe sizes are available for the En-Bloc Biopsy System Modification?
The modification offers four probe sizes: 10mm, 12mm, 15mm, and 20mm. These sizes correspond to the original cleared device specifications and are selected based on the clinical indication and tissue volume to be excised. Larger probes (e.g., 20mm) are suitable for deeper or larger tissue samples, while smaller probes (e.g., 10mm) may be preferred for superficial or delicate procedures.
Does the En-Bloc Biopsy System Modification require any special storage conditions?
The single-use probes should be stored in their original, sealed packaging in a clean, dry environment protected from extreme temperatures and direct sunlight. The reusable components (hand-held handle and control unit) should be stored according to the manufacturer’s guidelines, which typically include cleaning, disinfection, and proper maintenance to ensure longevity and functionality. Always refer to the included instructions for storage details.