The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Tristar Lp Torcar With Low Profile Threaded Sleeve.
| Device ID | K965045 |
| 510k Number | K965045 |
| Device Name: | TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ivan S Placko |
| Correspondent | Ivan S Placko ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-17 |
| Decision Date | 1997-05-05 |
| Summary: | summary |