The following data is part of a premarket notification filed by Genicon with the FDA for Genicon Suction Irrigation System.
| Device ID | K041967 |
| 510k Number | K041967 |
| Device Name: | GENICON SUCTION IRRIGATION SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENICON 427 LAKE HOWELL Maitland, FL 32751 |
| Contact | Gary Haberland |
| Correspondent | Gary Haberland GENICON 427 LAKE HOWELL Maitland, FL 32751 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-21 |
| Decision Date | 2004-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972007333 | K041967 | 000 |
| 00877972002772 | K041967 | 000 |
| 00877972002765 | K041967 | 000 |
| 00877972002758 | K041967 | 000 |
| 00877972002741 | K041967 | 000 |
| 00877972002734 | K041967 | 000 |
| 00877972002031 | K041967 | 000 |
| 00877972001935 | K041967 | 000 |
| 00877972001928 | K041967 | 000 |
| 00877972004370 | K041967 | 000 |
| 00877972004653 | K041967 | 000 |
| 00877972004677 | K041967 | 000 |
| 00877972007319 | K041967 | 000 |
| 00877972007012 | K041967 | 000 |
| 00877972006992 | K041967 | 000 |
| 00877972006978 | K041967 | 000 |
| 00877972006152 | K041967 | 000 |
| 00877972005155 | K041967 | 000 |
| 00877972004752 | K041967 | 000 |
| 00877972004738 | K041967 | 000 |
| 00877972001911 | K041967 | 000 |