The following data is part of a premarket notification filed by Advanced Medical Innovations, Inc. with the FDA for Advanced Medical Innovations Disposable Trocars And Laparoscopic Accessories.
| Device ID | K081398 |
| 510k Number | K081398 |
| Device Name: | ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ADVANCED MEDICAL INNOVATIONS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin ADVANCED MEDICAL INNOVATIONS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | GEI |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HET |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2009-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863634000491 | K081398 | 000 |
| 00863634000415 | K081398 | 000 |
| 00863634000422 | K081398 | 000 |
| 00863634000439 | K081398 | 000 |
| 00863634000446 | K081398 | 000 |
| 00863634000453 | K081398 | 000 |
| 00863634000460 | K081398 | 000 |
| 00863634000477 | K081398 | 000 |
| 00863634000484 | K081398 | 000 |
| 00863634000408 | K081398 | 000 |