510(k) clearance
Dynavisc
- 510(k) number
- K262343
- Applicant
- Fziomed, Inc.
- Decision date
- Oct 28, 2026
- Date received
- Jul 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OWW
- Device type
- Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II
- Regulation
- 21 CFR 878.3300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- San Luis Obispo, CA, US