The following data is part of a premarket notification filed by Surgiceye Gmbh with the FDA for Declipsespect Laparoscopy.
| Device ID | K133781 |
| 510k Number | K133781 |
| Device Name: | DECLIPSESPECT LAPAROSCOPY |
| Classification | Probe, Uptake, Nuclear |
| Applicant | SURGICEYE GMBH FRIEDENSTRASSE 18A Munich, Bavaria, DE 81671 |
| Contact | Moritz Hoyer |
| Correspondent | Moritz Hoyer SURGICEYE GMBH FRIEDENSTRASSE 18A Munich, Bavaria, DE 81671 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-12 |
| Decision Date | 2014-04-11 |