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 | K963160 |
| 510k Number | K963160 |
| Device Name: | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1997-06-27 |
| Summary: | summary |