The following data is part of a premarket notification filed by Genicon with the FDA for Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910.
| Device ID | K061417 |
| 510k Number | K061417 |
| Device Name: | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GENICON 6869 STAPOINT CT., SUITE 114 Winter Park, FL 32792 |
| Contact | Gary Haberland |
| Correspondent | Gary Haberland GENICON 6869 STAPOINT CT., SUITE 114 Winter Park, FL 32792 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2006-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972007357 | K061417 | 000 |
| 00877972002192 | K061417 | 000 |
| 00877972002185 | K061417 | 000 |
| 00877972002178 | K061417 | 000 |
| 00877972002161 | K061417 | 000 |
| 00877972002154 | K061417 | 000 |
| 00877972002017 | K061417 | 000 |
| 00877972002000 | K061417 | 000 |
| 00877972001997 | K061417 | 000 |
| 00877972001980 | K061417 | 000 |
| 00877972006251 | K061417 | 000 |
| 00877972006237 | K061417 | 000 |
| 00877972006213 | K061417 | 000 |
| 00877972006190 | K061417 | 000 |
| 00877972006015 | K061417 | 000 |
| 00877972005995 | K061417 | 000 |
| 00877972005971 | K061417 | 000 |
| 00877972002208 | K061417 | 000 |
| 00877972004615 | K061417 | 000 |
| 00877972006497 | K061417 | 000 |
| 00877972006954 | K061417 | 000 |
| 00877972006930 | K061417 | 000 |
| 00877972006916 | K061417 | 000 |
| 00877972006893 | K061417 | 000 |
| 00877972006879 | K061417 | 000 |
| 00877972006855 | K061417 | 000 |
| 00877972006831 | K061417 | 000 |
| 00877972006817 | K061417 | 000 |
| 00877972006794 | K061417 | 000 |
| 00877972006770 | K061417 | 000 |
| 00877972006756 | K061417 | 000 |
| 00877972006596 | K061417 | 000 |
| 00877972006572 | K061417 | 000 |
| 00877972006558 | K061417 | 000 |
| 00877972006534 | K061417 | 000 |
| 00877972006510 | K061417 | 000 |
| 00877972005957 | K061417 | 000 |