The following data is part of a premarket notification filed by Sharpe Endosurgical Corp. with the FDA for Endo-assist Laparoscopic Instruments.
| Device ID | K941494 |
| 510k Number | K941494 |
| Device Name: | ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | SHARPE ENDOSURGICAL CORP. 1839 BUERKLE RD. St. Paul, MN 55110 |
| Contact | W. Tim Miller |
| Correspondent | W. Tim Miller SHARPE ENDOSURGICAL CORP. 1839 BUERKLE RD. St. Paul, MN 55110 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-04-22 |