LM 1000 Cryosurgical Accessories
by Leisegang Medical, Inc. 510(k)
Active
510(k) K854767
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854767 | Date24 Jan 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Lm 1000
- 510(k) Number
- FDA Product Code
- GEH
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LM 1000 is a cryosurgical accessory designed for use in procedures involving controlled freezing of tissue. Classified as a cryosurgical unit accessory under FDA product code GEH, it operates within the regulatory framework for Class II devices (21 CFR 878.4350). These accessories are intended to facilitate cryosurgery, a minimally invasive technique used primarily in general and plastic surgery for targeted tissue destruction or preservation through extreme cold.
Supplied as single-use or reusable components (as indicated by the associated FEI numbers), the LM 1000 accessories are regulated under FDA’s 510(k) clearance (K854767) and fall under the Subcommittee for Urology (SU) advisory committee. No MRI safety or sterility specifications are explicitly stated in the data, though typical cryosurgical accessories may require sterile packaging for clinical use. Storage and handling comply with standard medical device protocols for cryogenic applications, ensuring proper functionality and safety in surgical settings.
Other devices from Leisegang Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the LM 1000 used for in surgical procedures?
The LM 1000 is a cryosurgical accessory designed to facilitate controlled freezing of tissue during minimally invasive procedures. It is primarily used in general and plastic surgery to achieve targeted tissue destruction or preservation through extreme cold, enabling precise surgical outcomes with reduced trauma.
How are LM 1000 accessories supplied, and what does the FEI number indicate?
LM 1000 accessories are supplied as either single-use or reusable components, as indicated by their respective FEI (Federal Equipment Identifier) numbers. The FEI number is a unique identifier assigned to each device variant, helping clinicians and purchasing departments distinguish between single-use and reusable models for proper inventory and compliance management.
Is sterility specified for the LM 1000, and how should it be stored?
The provided data does not explicitly state MRI safety or sterility specifications for the LM 1000. However, typical cryosurgical accessories used in clinical settings often require sterile packaging to prevent infection. Storage should follow standard medical device protocols for cryogenic applications, ensuring proper functionality, safety, and adherence to manufacturer guidelines.
What regulatory pathway does the LM 1000 follow, and which advisory committee oversees it?
The LM 1000 is regulated under the FDA’s 510(k) clearance pathway (K854767) and falls under the Subcommittee for Urology (SU) advisory committee, though its primary indication is for general and plastic surgery. The device was granted Substantially Equivalent (SESE) status under 21 CFR 878.4350, confirming its compliance with FDA requirements for Class II cryosurgical accessories.
Are there different models or sizes available for the LM 1000?
The LM 1000 is associated with multiple FEI numbers, which likely correspond to different models or variants of the accessory. These identifiers help differentiate between single-use and reusable components, as well as potentially varying sizes or configurations tailored for specific cryosurgical applications. For precise details on sizes or models, refer to the manufacturer’s documentation or contact Leisegang Medical, Inc.