The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Hx-5/6-1 Endoscopic Clipping Device.
| Device ID | K013066 |
| 510k Number | K013066 |
| Device Name: | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE |
| Classification | Ligator, Esophageal |
| Applicant | OLYMPUS AMERICA, INC. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-12 |
| Decision Date | 2001-12-11 |
| Summary: | summary |