Arthroscopic Grasper, Cup Forceps and Curettes
by T. Korossurgical Instruments Corp. 510(k)
Active
510(k) K954052
Overview
This device is an arthroscopic grasper, cup forceps, and curettes set, designed for use in arthroscopic surgical procedures. It includes instruments for grasping, manipulating, and removing tissue or debris within joints, typically during arthroscopic evaluations or repairs.
The set is intended for reusable use in orthopedic applications and has received FDA 510(k) clearance under K954052. Supplied sterile or non-sterile as specified by the manufacturer, these instruments are categorized under product code HRX and were reviewed by the Orthopedic (OR) Advisory Committee. No additional regulatory status beyond the stated 510(k) clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK954052 | Date6 Nov 1995 | 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- Withdrawn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
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Other devices from T. Korossurgical Instruments Corp.
Questions
What types of surgical procedures is this arthroscopic set designed for, and how does it assist during those procedures?
This set is specifically designed for arthroscopic surgical procedures, which involve minimally invasive techniques to visualize, diagnose, and treat joint issues. The included arthroscopic grasper, cup forceps, and curettes help surgeons grasp, manipulate, and remove tissue or debris within joints—such as cartilage, loose fragments, or synovial tissue—during evaluations or repairs like meniscus trimming, synovectomy, or joint debridement.
Is this device intended for single-use or reusable applications, and what does that mean for maintenance?
This device is explicitly designed for reusable use in orthopedic arthroscopic procedures. As a reusable instrument, it must be properly cleaned, sterilized, and maintained between uses to ensure safety and functionality. The manufacturer specifies whether it is supplied sterile or non-sterile, so facilities should follow their protocols for reprocessing to comply with clinical standards.
How do I know if this set is compatible with my existing arthroscopic equipment, and what regulatory pathway was followed for its approval?
This set falls under FDA 510(k) clearance (K954052) and is categorized under product code HRX, indicating it is intended for orthopedic arthroscopic use. The clearance was granted under the Traditional 510(k) pathway, meaning it was deemed substantially equivalent to a legally marketed device. While compatibility with specific arthroscopic systems depends on your equipment’s manufacturer, the design aligns with standard arthroscopic instruments, so most modern systems should support it.
Are there different sizes or models in this set, and how should they be stored to maintain their condition?
The specifications do not detail specific sizes or models beyond the general description of a grasper, cup forceps, and curettes set. For storage, since these instruments are reusable, they should be kept in a clean, dry environment—preferably in a dedicated instrument tray or case—to prevent damage or contamination. If supplied sterile, follow the manufacturer’s instructions for maintaining sterility until first use.