ORS-111
by O.R. Solutions, Inc. 510(k)
Active
510(k) K953654
Overview
The Ors-111 is a medical device classified under the general and plastic surgery specialty. It is designed to function within the parameters established for its product code category.
This device is identified by the K953654 submission and has received FDA 510K clearance. It is manufactured by O.R. Solutions, Inc. based in Chantilly, Virginia.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953654 | Date22 Sep 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- Withdrawn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
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from O.R. Solutions, Inc.
Questions
What is the intended use of the ORS-111?
The ORS-111 is a medical device specifically designed for use within the general and plastic surgery specialty. It functions according to the parameters established for its designated product code category.
What is the regulatory status of this device?
The ORS-111 has received FDA 510K clearance under submission number K953654. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Who is the manufacturer of the ORS-111?
The ORS-111 is manufactured by O.R. Solutions, Inc., which is based in Chantilly, Virginia. The company is the official applicant for the device's regulatory clearance.