General Surgical Instruments
510(k) K894670
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894670 | Date10 Aug 1989 | 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- Withdrawn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
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The General Surgical Instruments are classified as general-purpose surgical tools designed for use in a variety of surgical procedures. These instruments are essential for tasks such as cutting, grasping, retracting, dissecting, and suturing during operations, providing precision and control in surgical environments. They are engineered to meet the demands of general surgery, ensuring reliability and performance in clinical settings.
These instruments are supplied as reusable medical devices, intended for repeated use after proper cleaning, disinfection, and sterilisation. They are manufactured to comply with regulatory standards, including FDA 510(k) clearance under the product code DXC, and are intended for use in standard surgical settings. The instruments are designed for durability and longevity, supporting multiple reprocessing cycles while maintaining performance integrity. No specific MRI safety classification or single-use designation is indicated in the available data.
Questions
AI-generated answers, 1 Oct 2026
What are the Nopa General Surgical Instruments used for?
The Nopa General Surgical Instruments are versatile, reusable surgical tools designed for general surgical procedures. They are used for essential tasks such as cutting tissue, grasping and holding, retracting, dissecting, and suturing. Their precision and reliability make them suitable for a wide range of operations in standard surgical environments, ensuring clinicians maintain control and accuracy during procedures.
Are these instruments single-use or reusable?
These instruments are explicitly designed for reuse. After each use, they must undergo proper cleaning, disinfection, and sterilization to ensure safety and maintain performance. Their durable construction supports multiple reprocessing cycles while preserving functionality, making them cost-effective for clinical settings.
What regulatory approvals apply to these instruments?
The Nopa General Surgical Instruments hold FDA 510(k) clearance under product code DXC, classified as substantially equivalent to predicate devices. This clearance confirms compliance with U.S. regulatory standards for reusable surgical tools, ensuring they meet safety and performance requirements for use in clinical practice.
How should these instruments be stored?
Since these instruments are reusable, they should be stored in a clean, dry environment after sterilization to prevent contamination. Proper storage involves keeping them in a dedicated case or tray, away from direct sunlight or moisture, to preserve their integrity and ensure readiness for the next use cycle.
Do these instruments have any special safety considerations?
The available data does not specify an MRI safety classification for these instruments, meaning they should not be used in MRI environments unless confirmed safe by the manufacturer. Additionally, their reusable nature requires strict adherence to reprocessing protocols—cleaning, disinfection, and sterilization—to prevent cross-contamination and maintain performance.