The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Tenoscope.
| Device ID | K970642 |
| 510k Number | K970642 |
| Device Name: | TENOSCOPE |
| Classification | Arthroscope |
| Applicant | LUXTEC CORP. 45 PONTIAC RD. Newton, MA 02168 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress LUXTEC CORP. 45 PONTIAC RD. Newton, MA 02168 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-05-21 |