Versatile 1 Wound Vacuum System Modification
by Blue Sky Medical Group Incorporated
510(k) K052456
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052456 | Date4 Nov 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- Withdrawn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 Versatile 1 Wound Vacuum System
- 510(k) Number
- FDA Product Code
- OMP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Negative Pressure Wound Therapy Powered Suction Pump, designed to apply controlled suction to wounds or surgical sites. It promotes wound healing by removing excess fluids, gases, or infectious materials while maintaining a moist environment conducive to tissue regeneration.
The system is intended for use in clinical settings such as operating rooms, intensive care units, or wound care facilities. Supplied as a reusable medical device, it requires proper sterilization between uses and adheres to FDA regulatory standards under 878.4780. Authorized under FDA 510(k) clearance (K052456), it is classified as a Class II device and falls under the Special clearance type for modifications to existing systems.
Other devices from Blue Sky Medical Group Incorporated
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is this wound vacuum system designed for and how does it promote healing?
This device is specifically designed for use in clinical environments like operating rooms, intensive care units, and wound care facilities. It promotes wound healing by applying controlled suction to wounds or surgical sites, which helps remove excess fluids, gases, or infectious materials while maintaining a moist environment. This process supports tissue regeneration by reducing edema and enhancing granulation tissue formation.
Is this device single-use or reusable, and what sterilization process should be followed between uses?
The device is a reusable medical system, meaning it is intended for multiple uses in clinical settings. Between uses, it must undergo proper sterilization to ensure safety and effectiveness. The manufacturer recommends following standard sterilization protocols appropriate for medical devices, though specific instructions should be confirmed with Blue Sky Medical Group’s guidelines.
What regulatory pathway was followed for this modification to the Versatile 1 Wound Vacuum System?
This modification to the Versatile 1 Wound Vacuum System was authorized through the FDA’s 510(k) clearance process, specifically under the classification of a Class II device. The clearance (K052456) was granted as a special modification to an existing system, with the device falling under FDA regulation number 878.4780. The submission was reviewed by the FDA’s Surgical and Urological Devices Advisory Committee (SU).
Are there different models or sizes available for this wound vacuum system?
The provided data does not specify distinct models or sizes for this modification, but the device is associated with multiple registration numbers (e.g., 1419937, 1000208624, etc.), which may correspond to variations or accessories within the system. For precise details on available models or sizes, refer to Blue Sky Medical Group’s product documentation or contact their technical support.