The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Akro Vu Videoscopic Carpal Tunnel Release (vctr) System.
| Device ID | K092723 |
| 510k Number | K092723 |
| Device Name: | AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM |
| Classification | Arthroscope |
| Applicant | SKELETAL DYNAMICS, LLC 80 SHELDON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary SKELETAL DYNAMICS, LLC 80 SHELDON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2010-10-04 |
| Summary: | summary |