L.C.S.3000
by Cryodyne Technologies, Inc. 510(k)
Active
510(k) K926464
Overview
The L.C.S.3000 is a cryosurgical unit accessory classified as a medical device under product code GEH. It is a substantially equivalent device cleared through the traditional 510(k) pathway, with decision date August 24, 1993, and K-number K926464.
The device is supplied by Cryodyne Technologies, Inc., with manufacturing address in Oak Hill, NY, and is associated with multiple facility establishment identifiers and registration numbers. It is regulated under regulation number 878.4350 and falls under the medical specialty of general and plastic surgery.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926464 | Date24 Aug 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Cryodyne Technologies, Inc.
Questions
What is the L.C.S.3000 used for?
The L.C.S.3000 is a cryosurgical unit accessory intended for use in general and plastic surgery procedures, as indicated by its product code GEH and medical specialty description.
How is the L.C.S.3000 supplied and by whom?
The L.C.S.3000 is supplied by Cryodyne Technologies, Inc., with manufacturing operations located in Oak Hill, NY, and is associated with multiple facility establishment identifiers and registration numbers.
What regulatory pathway was used for the L.C.S.3000 clearance?
The L.C.S.3000 was cleared through the traditional 510(k) pathway as a substantially equivalent device, with decision date August 24, 1993, and K-number K926464.