GenVisc 850
by Channel-Markers Medical, LLC
PMA P140005
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP140005 | Date2 Sep 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Acid, hyaluronic, intraarticular
- PMA Number
- FDA Product Code
- MOZ
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The GenVisc 850 is an intraarticular hyaluronic acid injection designed for the treatment of osteoarthritis (OA) of the knee. It is classified as an acid, hyaluronic, intraarticular device and is intended for patients who have not responded adequately to conservative non-pharmacologic therapy and simple analgesics, such as acetaminophen.
This device is supplied as a sterile, single-use injection for intraarticular administration in orthopedic settings. It is approved under an FDA PMA (Premarket Approval) and falls under product code MOZ. The device is packaged for clinical use in controlled environments and adheres to regulatory standards for intraarticular viscosupplementation.
Other devices from Channel-Markers Medical, LLC
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical use for the GenVisc 850, and who is it intended for?
The GenVisc 850 is an intraarticular hyaluronic acid injection specifically approved for treating pain in osteoarthritis (OA) of the knee. It is intended for patients who have not responded adequately to conservative non-pharmacologic therapies and simple analgesics, such as acetaminophen.
How is the GenVisc 850 supplied, and is it reusable?
The GenVisc 850 is supplied as a sterile, single-use injection, meaning each package is intended for one-time use in a clinical setting. This ensures safety and sterility for intraarticular administration.
What regulatory pathway was followed for the approval of the GenVisc 850?
The GenVisc 850 was approved under an FDA Premarket Approval (PMA) process, which is a rigorous regulatory route for high-risk medical devices like intraarticular viscosupplements. The approval was granted on September 2, 2015, under PMA number P140005.
Is the GenVisc 850 intended for use in any specific medical specialty?
While the device is classified under the product code MOZ and falls within the orthopedic advisory committee category (OR), the medical specialty description in the registry is listed as 'Unknown.' This means the device is primarily intended for orthopedic use in treating knee osteoarthritis, not for any specific subspecialty.