Arthrocombi 5003
by F.M. Wiest USA, Inc. 510(k)
Active
510(k) K871181
Overview
The Arthrocombi 5003 is an arthroscopic surgical instrument designed for joint procedures, specifically classified under the FDA’s Product Code HRX. This device is intended for use in arthroscopic surgeries, facilitating visualization and manipulation within joint cavities to aid in diagnostic and therapeutic interventions.
Supplied as a reusable medical instrument, the Arthrocombi 5003 is intended for use in controlled surgical environments such as operating rooms. It was granted FDA 510(k) clearance under the Traditional pathway in 1987, with a decision classification of Substantially Equivalent to a predicate device. The device is regulated under the Orthopedic advisory committee and requires proper sterilization and maintenance per manufacturer guidelines to ensure safety and efficacy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871181 | Date29 Sep 1987 | 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- Withdrawn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
- SESE Substantially Equivalent
Other devices from F.M. Wiest USA, Inc.
Questions
What is the Arthrocombi 5003 used for in arthroscopic surgeries?
The Arthrocombi 5003 is designed specifically for arthroscopic procedures to assist in joint visualization and manipulation within joint cavities. It aids clinicians in performing diagnostic evaluations and therapeutic interventions, such as removing debris, accessing internal structures, or preparing surgical sites, during minimally invasive joint surgeries.
Is the Arthrocombi 5003 a single-use or reusable device?
The Arthrocombi 5003 is supplied as a reusable medical instrument. To maintain safety and efficacy, it must undergo proper sterilization and maintenance procedures as outlined by the manufacturer before each use in controlled surgical environments like operating rooms.
What regulatory pathway was followed for FDA clearance of the Arthrocombi 5003?
The Arthrocombi 5003 received FDA 510(k) clearance through the Traditional pathway in 1987. It was classified as Substantially Equivalent (SESE) to a predicate device, meaning it was determined to have the same intended use, technological characteristics, and performance as a legally marketed device already on the market.
Which advisory committee oversees the regulatory review of the Arthrocombi 5003?
The Orthopedic Advisory Committee (OR) within the FDA oversees the regulatory review for the Arthrocombi 5003. This committee provides expert guidance on orthopedic devices, including arthroscopic instruments, to ensure their safety and effectiveness for intended clinical use.
How should the Arthrocombi 5003 be stored and maintained?
The Arthrocombi 5003 must be stored and maintained according to the manufacturer’s guidelines to preserve its functionality and sterility. Proper cleaning, sterilization, and inspection between uses are critical to prevent contamination and ensure reliable performance during arthroscopic procedures.