Novaspine Powered Suction Pump PRO-1
510(k) K062456
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062456 | Date16 Oct 2006 | 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- Withdrawn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
- 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
The Novaspine Powered Suction Pump Pro-1 is a Negative Pressure Wound Therapy Powered Suction Pump, designed to apply continuous or intermittent negative pressure for medical suction procedures. It removes secretions, blood, and other body fluids from surgical sites, airways, or respiratory systems to facilitate wound healing and maintain patient safety during procedures.
This portable, battery-powered device is intended for single-use applications in clinical settings such as operating rooms, recovery areas, or intensive care units. It is classified as a Class II medical device under FDA regulations (21 CFR 878.4780) and holds a 510(k) clearance (K062456) for substantial equivalence in general and plastic surgery applications. The device is not MRI-safe and must be stored in a clean, dry environment as specified by the manufacturer.
Other devices from Novaspine, LLC
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the Novaspine Powered Suction Pump Pro-1 designed for, and how does it differ from standard suction devices in those environments?
The Novaspine Powered Suction Pump Pro-1 is specifically designed for use in clinical settings like operating rooms, recovery areas, and intensive care units. Unlike traditional suction devices, it applies continuous or intermittent negative pressure to remove secretions, blood, and other fluids from surgical sites, airways, or respiratory systems. This helps facilitate wound healing and maintain patient safety during procedures, particularly where precise fluid management is critical.
Is the Novaspine Powered Suction Pump Pro-1 reusable, or is it intended for single-use only? How should it be handled after use?
The device is explicitly designed for single-use applications in clinical settings. After use, it should be disposed of according to standard medical waste protocols to ensure patient safety and prevent cross-contamination.
What storage conditions are required for the Novaspine Powered Suction Pump Pro-1 to maintain its functionality?
The manufacturer specifies that the device must be stored in a clean, dry environment. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could compromise its performance or integrity.
Does the Novaspine Powered Suction Pump Pro-1 have any special considerations for use in imaging procedures, such as MRI?
The device is not MRI-safe, meaning it should not be used or stored near MRI equipment. This is an important consideration for facilities where both suction therapy and MRI procedures are performed.
What regulatory pathway was followed for the Novaspine Powered Suction Pump Pro-1, and what does this mean for its use in general and plastic surgery?
The device holds a 510(k) clearance (K062456) under the FDA’s Traditional pathway, demonstrating substantial equivalence to a predicate device. This clearance was granted for use in general and plastic surgery applications, confirming its suitability for these specialties while adhering to FDA Class II medical device regulations (21 CFR 878.4780).