The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Gyrus Plasmacision Laparoscopic Spatula.
| Device ID | K041633 |
| 510k Number | K041633 |
| Device Name: | GYRUS PLASMACISION LAPAROSCOPIC SPATULA |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, SUITE 160 Maple Grove, MN 55311 -3602 |
| Contact | David E Chadwick |
| Correspondent | David E Chadwick GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, SUITE 160 Maple Grove, MN 55311 -3602 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-16 |
| Decision Date | 2004-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009776 | K041633 | 000 |
| 00821925010451 | K041633 | 000 |