GORE SMOOTHER II AND GORE BPTB
Device Facts
| Record ID | K941269 |
|---|---|
| Device Name | GORE SMOOTHER II AND GORE BPTB |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | HRX · Orthopedic |
| Decision Date | May 19, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
