The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Gyrus Open Forceps.
| Device ID | K024286 |
| 510k Number | K024286 |
| Device Name: | GYRUS OPEN FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, # 105 Minneapolis, MN 55311 -3602 |
| Contact | Mark Jensen |
| Correspondent | Mark Jensen GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, # 105 Minneapolis, 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 | 2002-12-23 |
| Decision Date | 2003-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009448 | K024286 | 000 |
| 00821925010574 | K024286 | 000 |