The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Essex Endoscope, Model Sxd-1000.
| Device ID | K023627 |
| 510k Number | K023627 |
| Device Name: | ESSEX ENDOSCOPE, MODEL SXD-1000 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Anne Schlagenhaft |
| Correspondent | Michelle Weidman N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-10-28 |
| Decision Date | 2002-11-12 |
| Summary: | summary |