The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System.
| Device ID | K072594 |
| 510k Number | K072594 |
| Device Name: | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM |
| Classification | Kit, Nephroscope |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham A Baillie |
| Correspondent | Graham A Baillie GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FGA |
| Subsequent Product Code | FEC |
| Subsequent Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2007-12-13 |
| Summary: | summary |