The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Trocar Sheath Anchor.
| Device ID | K915116 |
| 510k Number | K915116 |
| Device Name: | TROCAR SHEATH ANCHOR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ORIGIN MEDSYSTEMS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Contact | Richard Rush |
| Correspondent | Richard Rush ORIGIN MEDSYSTEMS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-06-12 |