General & Plastic Surgery Instruments
510(k) K152400
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152400 | Date22 Jan 2016 | 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- Withdrawn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
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device comprises a range of surgical instruments designed for general and plastic surgery procedures. It includes tools such as forceps, retractors, and other hand instruments used for dissection, grasping, and manipulation of tissues during operative interventions.
The instruments are supplied as reusable surgical tools, intended for use in sterile operating room environments. They are classified under product code GCJ and have received FDA 510(k) clearance through a traditional review process, with a decision date of January 22, 2016. No specific sterility or MRI safety information is provided in the data.
Other devices from Sontec Instruments, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these instruments designed for single-use or can they be reused in multiple procedures?
These instruments are explicitly labeled as reusable surgical tools, meaning they are intended for repeated use in sterile operating room environments after proper cleaning, sterilization, and maintenance. Since they are not classified as single-use, they must be processed according to established hospital protocols to ensure safety and sterility between procedures.
What types of surgical procedures are these instruments commonly used for?
The instruments are part of a general and plastic surgery toolset, which includes forceps, retractors, and dissection tools. They are designed for tissue manipulation, grasping, and exposure during operative interventions, such as incisions, excisions, or reconstructive procedures. While the product code (GCJ) suggests a broad surgical application, their specific use depends on the surgeon’s discretion within sterile environments.
How are these instruments supplied, and do they come in different sizes or models?
The data does not specify exact sizes or models, but as a range of surgical instruments, they are likely supplied as a kit or tray containing multiple tools (e.g., forceps, retractors) for general and plastic surgery. For precise sizing or model variations, you would need to consult the manufacturer’s catalog or packaging details, as the provided information focuses on regulatory classification rather than product configuration.
What should I consider regarding storage and handling to maintain their condition?
Since these are reusable instruments, proper storage is critical to prevent damage or contamination. They should be stored in a clean, dry environment (e.g., instrument trays or sterilization pouches) away from direct sunlight or moisture. Before use, they must undergo sterilization as per hospital protocols, and after use, they should be cleaned and inspected for wear or defects before reprocessing. The manufacturer’s instructions (not provided here) would detail specific storage recommendations.
How can I verify the regulatory compliance of these instruments before purchasing?
These instruments carry an FDA 510(k) clearance (K152400) under product code GCJ, granted through a traditional review process by the Gastroenterology/Urology advisory committee. To confirm compliance, you can verify the clearance status via the FDA’s [Premarket Notification (510(k)) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) using the K-number (K152400). Always cross-check with the manufacturer (Sontec Instruments, Inc.) for any updates or additional certifications.