The following data is part of a premarket notification filed by Genicon, Inc with the FDA for Ezee Retrieval.
| Device ID | K162059 |
| 510k Number | K162059 |
| Device Name: | EZEE RETRIEVAL |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENICON, INC 6869 STAPOINT COURT SUITE 114 Winter Park, FL 32792 |
| Contact | Katlyn Kachman |
| Correspondent | Katlyn Kachman GENICON, INC 6869 STAPOINT COURT SUITE 114 Winter Park, FL 32792 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2016-09-29 |
| Summary: | summary |