The following data is part of a premarket notification filed by Kinetix Instruments with the FDA for Endoscopic Carpal Tunnel Release System.
| Device ID | K933470 |
| 510k Number | K933470 |
| Device Name: | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM |
| Classification | Arthroscope |
| Applicant | KINETIX INSTRUMENTS 2396 WALSH AVE. Santa Clara, CA 95051 -1301 |
| Contact | Michael R Billingsley |
| Correspondent | Michael R Billingsley KINETIX INSTRUMENTS 2396 WALSH AVE. Santa Clara, CA 95051 -1301 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-16 |
| Decision Date | 1994-03-25 |