The following data is part of a premarket notification filed by Pollux Endoscopy, Inc. with the FDA for Laparascope.
| Device ID | K943662 |
| 510k Number | K943662 |
| Device Name: | LAPARASCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | POLLUX ENDOSCOPY, INC. 4696 N.W. 103RD AVE. Sunrise, FL 33351 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1995-05-25 |